Workforce Development (WD)

Institutional Career Development Program

Mentee Handbook 2016 WD Contact 2001 N. Soto Street, SSB210A Los Angeles, CA 90033 Telephone: 323.442.8281 Email: [email protected] | Twitter: @SCCTSIEducation

Version 8/12/16

Welcome to the Institutional Career Development (CTR) Program “Education is the bridge to new discoveries and the future of medicine.” Welcome CTR Scholars! We are pleased to welcome you to the Southern California Clinical and Translational Science Institute’s (SC CTSI) CTRClinical and Translational Research (CTR) program (formerly known as the KL2 Program). You have been selected among many exceptional candidates from various departments and schools of the University of Southern California. The Workforce Development (WD) core is looking forward to working with you and your mentors over the next three years within this new and exciting program. During your time as a CTR CTR Scholar, we expect you to thrive within multidisciplinary teams that include mentors, and fellow scholars. This program will give you the opportunity to build the skills you will need to become a successful clinical/translational researcher. This informational booklet outlines the program guidelines, contact and resource information, educational schedule, mentoring program and the contracts you and your mentors need to sign and return to WD. We request that you read the booklet carefully, fill out all the necessary paperwork, sign the contracts and return them by August 31, 2016 to WD. Please contact the WD office to discuss any questions or concerns as a CTR Scholar. We are here to assist you and committed to ensuring that you have a positive, meaningful and successful experience. Sincerely, Jonathan M. Samet, MD, MS Director, WD Professor and Flora L. Thornton Chair Department of Preventive Medicine

Alex Capron, LLB Director of Research Ethics, WD Scott H. Bice Chair in Healthcare Law, Policy, and Ethics Professor of Law and Medicine Gould School of Law

Cecilia M. Patino-Sutton, MD, MEd, PhD Director of Education, WD Assistant Professor Department of Preventive Medicine

Table of Contents WD & SC-CTSI Overview Southern California Clinical and Translational Science Institute (SC CTSI)……………………… Workforce Development (WD)………………………………..……………………………..………………….… WD Office………………………………………………………………………………………..……………………………. WD Leadership and Staff………………………………………………………………………..……………………..

Pgs. 1-3 1 1 1 2-3

CTR Program Overview CTR Program……………………………………………………………………………………………………………….. MD List of Competencies………………………………………………………………………………………………. Master of Science in Clinical, Biomedical, and Translational Investigations……………………. KL2/CTR Scholars, TL1 Trainees and Mentors List………………………………………………………….. Scholar Resources………………………………………………………………………………………………………….

Pgs. 4-17 4 4 4-6 7-14 15-17

Academic Calendar Program Coursework……………………………………………...……………………………………………………. Career Development Seminar Sessions (CDSS)……………………………………………………………… Work-in-Progress…………………………………………………………………………………………………………… Annual Progress Report…………………………………………………………………………………………………. Annual Translational Science Meeting………………………………………………………………………….. Prior to Completion of CTR Appointment/Program…………………………………………………….. Post Completion of CTR Appointment…………………………………………………………………………. WD Academic Calendar……………………………………………………………………………………………..

Pgs. 18-26 18 19 19 19 19 20 20 21-26

Policies, Procedures, Requirements, and Expectations for CTR Scholars Terms of WD Award………………………………………………………………………………………………………. NIH xTrain Appointment Process…………………………………………………………………………………… IRB/IACUC Approval………………………………………………………………………………………………………. Notification of Adverse Events to NCATS……………………………………………………………………… Program Commitment and Percent Effort……………………………………………………………………… Core Didactic Coursework and Training…………………………………………………………………………. WD Program Evaluations…………………………………………………………………………………………… Attendance……………………………………………………………………………………………………………………. Clinical Privileges…………………………………………………………………………………………………………… Calendar and Holiday Schedule……………………………………………………………………………………… Vacation and Other Time Away……………………………………………………………………………………… Parental Leave……………………………………………………………………………………………………………….. Department Clearance (d-clearance) ……………………………………………………………………………. Registration Procedure for Courses as Limited Status Employee (USC Employee Only)…. Tuition Remission Process if Accepted into MS Program……………………………………………….. Promotions & Annual Salary Merit Increases………………………………………………………………… International Research…………………………………………………………………………………………………… Citations for Grant Support or Publications……………………………………………………………………. Obtaining PMCID Number for Publications……………………………………………………………………. Sexual Harassment Hotline…………………………………………………………………………………………….

Pgs. 27-37 27 27-32 32 32 32 33 33 33 33 33 33 33 33 34 35 35 35 35 36 36

Student Loan Deferred………………………………………………………………………………………………….. Tax Documentation……………………………………………………………………………………………………….. Disability Services…………………………………………………………………………………………………………..

36 37 37

CTR Scholar Support CTR Salary Support………………………………………………………………………………………………………. CTR Research Related Expenses and Tuition………………………………………………………………..

Pgs. 38-47 38 38-47

Mentee and Mentor Requirements Mentor/Mentee Interaction Form…………………………………………………………………………………. Contract of Commitments/Terms of the CTR Award for the Mentee and Mentor(s)…… Commitments of a Mentee as Terms of the CTR Award ……………………………………………… Commitments of a Mentor(s) as Terms of the CTR Award …………………………………………..

Pgs. 48-56 49-51 52 53-54 55-56

Southern California Clinical and Translational Science Institute (SC CTSI) and the Workforce Development core (WD) “Translating science into solutions for better health” The University of Southern California established the Southern California Clinical and Translational Science Institute (SC CTSI) in 2006 to promote scientific discoveries and their application in real-life settings and to improve public health and health care. Faculty from eight USC schools and Children’s Hospital Los Angeles partnered with the Los Angeles County health system, the Community Clinic Association of L.A. and more than 30 other community health organizations in greater Los Angeles to address the specific needs of the urban and diverse patient populations in the L.A. basin. USC’s Keck School of Medicine received a prestigious Clinical Translational Science Award (CTSA) from the National Institutes of Health (NIH) in 2010 to support the expansion of the SC CTSI. This five-year grant was the first such award funded in Los Angeles. SC CTSI’s ultimate mission is to connect basic scientists to clinical and community researchers and practitioners to accelerate the pace at which research discoveries are translated into practice. Another of SC CTSI’s goal is to provide training to new basic and clinical researchers in team science. This work environment encompasses scientists and clinicians who are team-oriented to efficiently address important health problems based on the communities’ needs. “Educating future clinical translational scientists to improve health issues in diverse, urban populations”

Workforce Development core (WD) houses the educational activities of the SC CTSI. WD is designed to provide multiple points of entry into the clinical and translational research training experience, regardless of current level of experience, disciplinary expertise, or professional setting (laboratory, clinic, or community). WD’s vision is to develop and deliver innovative programs that educate students, fellows, faculty, staff, community providers and others in bi-directional translation to the benefit of our diverse, urban population and the nation as a whole. WD draws on the full faculty of USC and our CTSI partners to function as the focal point for developing and offering innovative education that provides the competencies needed for clinical and translational research in diverse, urban populations. WD Office The WD office is the physical home of the CTR Training Program. Address: 2001 Soto Street, SSB210A, Los Angeles, CA 90033-9234 Main Phone: 323 442 8281 WD Email: [email protected] Program Website: http://sc-ctsi.org/workfoce-development Education Content Management System: http://moodle.sc-ctsi.org Twitter: @SCCTSIEducation

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WD Leadership and Staff Jonathan M. Samet, MD, MS — Director Dr. Samet, a pulmonary physician and epidemiologist, is currently Professor and Flora L. Thornton Chair for the Department of Preventive Medicine at the Keck School of Medicine at USC and Director, USC Institute for Global Health. From 1994 through 2008, he was Professor and Chairman of the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. His research has focused on the health risks of inhaled pollutants—particles and ozone in outdoor air and indoor pollutants including secondhand smoke and radon and he has also investigated the occurrence and causes of cancer and respiratory diseases. He has also taught extensively on methods for epidemiological research and for clinical/translational research. He has served on numerous national and international committees concerned with using scientific evidence for the development of policy to protect public health. Dr. Samet is responsible for leadership of all aspects of the WD and will oversee development of the general education curriculum/materials, and to assure effective functioning of the WD. Phone: 323 865 0803 Email: [email protected]

Cecilia M. Patino-Sutton, MD, MEd, PhD — Director of Education Dr. Cecilia Patino-Sutton has a Master’s in Education and a medical degree from Argentina specializing in Allergy and Clinical Immunology, received training as a clinical researcher in the Division of Pulmonary and Critical Care Medicine at Johns Hopkins University, and has a PhD in Epidemiology from the Department of Preventive Medicine at USC. As Education Director, she is responsible for working with faculty to develop, coordinate, and help teach lectures and courses for all aspects of the WD. Dr. Patino-Sutton is also responsible for coordinating the WD’s minority recruitment efforts with partnering programs and institutions. Phone: 323 442 8295 Email: [email protected]

Alexander Capron, LLB — Director of Research Ethics Alexander Capron is a University Professor and Scott H. Bice Chair in Healthcare, Law, Policy, and Ethics at the University of Southern California. He is globally recognized for his expertise in health policy and medical ethics. He teaches Public Health Law, Torts, and Law, Science, and Medicine. He also teaches at the Keck School of Medicine of USC and is co-director of the Pacific Center for Health Policy and Ethics, a campus-wide interdisciplinary research and education center. As Director of the Research Ethics component, Alex will identify educational and training needs and help develop program curriculum and materials related to ethics. He will also provide consultation to PIs in the handling of ethical issues that arise during the conduct of research, and lead original research with CTSI and outside scholars on novel research ethics issues. Phone: 213 740 2557 Email: [email protected]

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Emil Bogenmann, PhD, EdD — Mentoring Advisor Dr. Bogenmann is an Associate Professor of Pediatrics at CHLA and Molecular Microbiology and Immunology at USC’s Keck School of Medicine. Dr. Bogenmann has been involved in training high school students, undergraduates, graduate students, and post-doctoral fellows and has served as the Director of Research Education at CHLA since 1995. Also, he was the former Director of the TL1 Program. As Mentoring Advisor, Dr. Bogenmann is responsible for providing mentoring education to Scholars, Trainees, and USC workforce. Phone: 323 361 5650 Email: [email protected]

Elizabeth Zelinski, PhD — K Series Grant Advisor Dr. Zelinski is the Rita and Edward Polusky Chair in the Education and Aging, Professor of Gerontology and Psychology at USC’s Davis School of Gerontology. Dr. Zelinski has extensive knowledge and experience as an NIH reviewer and a superb ability to uses that background in helping Scholars to write successful applications. She has provided one-on-one coaching with our Scholars and Trainees on their grants prior to NIH submission. Phone: 213 740 4918 Email: zelinski.usc.edu

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Melissa Wilson, MPH, PhD — Faculty Instructor Dr. Wilson is Assistant Professor of Research in the Division of Maternal-Fetal Gynecology at the University of Southern California. She received her Baccalaureate degree in Biology from the University of Pittsburgh, her MPH degree in Epidemiology from the University of California at Los Angeles in 1994, and her PhD in Epidemiology from the University of Southern California in 2004. After completing her postdoctoral research at USC, she joined the Division of Maternal-Fetal Medicine at USC in March, 2006. Dr. Wilson’s research interests include the molecular epidemiology of preeclampsia and HELLP Syndrome, the genetics of nausea and vomiting of pregnancy, the effects of air pollution on obstetric outcomes and post-partum depression. As a faculty Instructor, she is responsible for teaching clinical translational research courses for the CTR Scholars. Phone: 323 226 3416 Email: [email protected]

Jeanne Dzekov McKean, BA — Program Administrator Jeanne has worked in research as a research coordinator and program specialist for cancer clinical trials, endocrine investigator-initiated studies at Charles R. Drew University and ophthalmic epidemiologic studies at USC’s Department of Ophthalmology. As Program Administrator, Jeanne helps implement the educational programs, assist CTR awardees with administrative and educational issues, as well as the long-term tracking of all awardees. Phone: 323 442 7289 Email: [email protected]/[email protected]

Alicia Fairbrother, MPH — Temporary Program Assistant Alicia’s previous work has included community outreach, grant management and research coordination domestically and abroad, along with receiving her Master’s in Public Health from the University of Southern California. As the current program assistant, Alicia supports the Program Administrator and the Workforce Development Co-Director in the daily administrative and educational duties of the Workforce Development core of SC CTSI. Phone: 323 442 8281 Email: [email protected]

Gary San Angel — Distance Education Operations Specialist Gary is responsible for providing technical support and infrastructure for lecture capture, videoconferencing, and other collaboration applications as it relates to distance learning. Gary brings his technical expertise in classroom technology and distance education from Drexel University and the Perelman School of Medicine at the University of Pennsylvania. Phone: 323 442 8282 Email: [email protected]

Pulmonary and Critical Care Medicine at Johns Hopkins University, and has a PhD in aspects of the WD. She will also work with the CBIS staff to design a

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Institutional Career Development (CTR) Program Overview The CTR Program This three-year program provides multi-disciplinary, team-based clinical and translational research education to a select group of Scholars. As a Scholar, you will acquire the advanced scientific competencies necessary to perform clinical and translational research, including research related to health problems in diverse populations. The fundamental training and career development elements in this program revolve around a structured didactic coursework and seminars in the aspects of design, conduct and analysis of clinical research in a team-based setting; and engagement in related career development activities (e.g. conferences, mentoring program); and “hands on” conduct of a research project under the supervision of mentors. Even though financial support is only provided for two years, WD expects the Scholars to participate in the program for a third year. Completion of the CTR training requirements will lead to either a Certificate in Clinical, Biomedical, and Translational Investigations or a Master’s Degree in Clinical Biological, and Translational Investigations (CBTI). With regards to the MS in CBTI, more information is provided in this section of the handbook. CTR Core Competencies Scholars are expected to acquire and refine the core competencies listed below during their tenure in the program. These competencies reflect an overarching and integrated knowledge-based set of skills that go beyond the objectives of individual courses and represent the core knowledge and skills needed for scholars to become productive clinical translational investigators. These include:         

Conducting literature evaluation and synthesis, Formulating clinical and translational research questions, Proposing study designs aligned with specific research questions, Applying statistical approaches aligned with specific research questions, Illustrating processes used to carry out clinical translational research , Explaining the importance of responsible conduct of research, Recognizing the advantages and limitations of biomedical informatics in research, Utilizing leadership, scientific communication, and translational teamwork skills, and Describing community engaged research in diverse, urban populations.

Master of Science in Clinical, Biomedical, and Translational Investigations (CBTI) Scholars are highly encouraged to obtain a Master of Science in Clinical, Biomedical, and Translational Investigations (CBTI) from the Keck School of Medicine if they do not already have a similar master’s degree. This MS program is a joint effort to train medical students, residents or fellows or other health professionals including faculty and other scientists conducting clinically-related research, in clinical research methods to translate clinical, biomedical and technological discoveries into advances in population-based, clinical or basic science research. This MS program is primarily for individuals with professional degrees in the health sciences at USC or CHLA, and faculty interested in advancing their research career. Tracks include: 1) clinical translational research, 2) patient-oriented research, 3) community-based intervention trials, 4) design, conduct and analysis of clinical studies, 5) epidemiology

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and disease etiology, 6) molecular biology, 7) cell biology, 8) health outcomes research, 9) vision science, 10) environmental epidemiology, and 11) alternative options track. Applicants must apply and meet the minimum requirements for admission to the Graduate School. The Curriculum Office at Keck School of Medicine administers the MS program in coordination with the Workforce Development (WD), Stanley P. Azen, PhD, Professor, Co-Director of Biostatistics, Preventive Medicine, Co-Director WD and Michael L. Paine, BSc, DDS, PhD, Associate Professor, Director, Graduate Program in Craniofacial Biology, Co-Directors, oversees the program along with faculty preceptors. The MS program in Clinical, Biomedical, and Translational Investigations is designed to train doctoral and post-doctoral students, fellows and faculty for future independent research careers in an academic, government or private sector setting. The objective of the MS program is to produce a clinical researcher with either an in-depth knowledge in laboratory methodologies or statistical and analytic skills in population-based, clinical studies or outcomes research. The program gives students a solid background in the methodological aspects of translational research, and in statistical thinking as applied to epidemiology, as well as a solid grounding in biostatistics, epidemiological methods, and community based intervention strategies. Admission Requirements The Program will consider applicants who satisfy all requirements for admission to the Graduate School. For the MS program in Clinical, Biomedical, and Translational Investigations, MCAT scores may be substituted for the GREs. Applicants not meeting Graduate School requirements for regular standing may, with approval of the Graduate School, be admitted on a conditional basis. Regular standing is contingent upon maintaining a GPA of 3.0 in the first 12 units of graduate studies. All graduate students must maintain a GPA of 3.0 throughout their graduate studies. General Requirements Graduation requires the completion of a minimum of 29 units, of which a minimum of 15 units are didactic course credits taken in the first year (including summer sessions), with the remaining units being directed to: a) PM 590 (directed research) and PM 594ab (thesis, 4 units) taken in the second year. The equivalent of one year of full-time effort must be devoted to research leading to the completion of master’s thesis. The thesis provides a structure for the development of a plan to address a research problem and a suitable approach to the analysis and presentation of the results. Because the background and interests of applicants varies widely, one of the Co-Directors will consult with each student prior to the first year in order to design an individualized schedule of recommended courses, or this may be negotiated with a student’s faculty sponsor. At the end of the first year, the trainee must submit a final program plan to the Co-Directors. This will summarize the courses taken, the proposed thesis title, and the names and credentials of the MS Thesis Committee. One of the members of the MS Thesis Committee will be the trainee’s research advisor and will serve as the Chair of the committee. At least one member of the Thesis Committee must be from outside the student’s department. For faculty, at least two members of the Thesis Committee must be from outside the student’s department. If you are interested in obtaining more information on the MS in Clinical, Biomedical, and Translational Investigations Program, you may contact the Program Administration via phone (323) 442-2965, email at [email protected], or proceed to the program’s website (http://keck.usc.edu/en/Education/Degrees_and_Programs/MD_Program/MD_MS_Program.aspx). You 5

may enroll online for the MS program by going to https://www.usc.edu/admission/graduate/applyonline/ and follow the instructions provided.

Applying to the M.S or Certificate Program in Clinical, Biomedical, and Translational Investigations Please read the application steps below and follow them carefully: 1. Complete the Pre-Application along with the essay questions on page 2 (email the PreApplication to [email protected], by fax 323-442-2318, US mail to 1975 Zonal Avenue, KAM 200, Los Angeles, CA 90089, Attn: MS Program Office, Roland Rapanot) 2. Submit at least two recommendation letters 3. Submit official MCAT, GRE, or USMLE scores 4. Submit official transcripts from undergraduate, graduate or professional school 5. Complete the Graduate Online Application (website is on page 2 of the Pre-Application) 6. Submit all application materials 6 weeks prior to the start of the semester you wish to matriculate 7. IF you already have health insurance (through work or other Graduate Program), please contact the insurance coordinator, Sylvia Carabante, to waive the University insurance. She can be reached at 323-442-5989 or [email protected]. This must be done at the beginning of the semester. 8. IF you qualify for tuition remission, the Tuition Assistance Form must be completed EVERY semester to receive the benefit. To find out if you qualify, please contact the Benefits Office at 213-740-6027 or [email protected]. The Tuition Assistance Form can be requested by emailing [email protected]. Once you complete the form, please mail it to 1975 Zonal Avenue, KAM 200, Los Angeles, CA 90089, Attn: MS Program Office, Roland Rapanot. Please do not fax or email the form; the original form with your signature is required. 9. For questions or further information, please contact MS Program Office at 323-442-2965 or [email protected].

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CTR Scholars / TL1 Trainees and Mentors List Award Type

Name

TL1

Tanya Alderete

Duration

10/15/10-10/14/12

TL1

Ian Holloway

Duration

10/15/12- 3/31/11

TL1

Jamaica Rettberg Perry

Degree

BA, PhD

10/15/10-10/14/12

TL1

Melissa Warden Pronold

Duration

10/15/2010-4/11/12

KL2

Kimberly Aldinger

Duration

10/15/10 -10/14/11

KL2

Robert J Brown

Duration

10/15/10 -10/14/13

KL2

William J Mack

Duration

10/15/10 -10/14/13

KL2

Kathleen Page

Duration

10/15/2010 - 8/11

KL2

Alex Balekian

Duration

10/15/10 -10/14/13

TL1 Alumna/ Graduated/Postdoctoral Fellow, USC Preventive Medicine

USC Department / School Systems Biology & Disease/ Keck School of Medicine

Contact Information

Primary Mentor

[email protected] u

Michael Goran, PhD 323 442 3027 [email protected]

Co-Mentor(s) Fred Sattler, MD [email protected] Kathleen Page, MS, MD [email protected]

TL1 Alumnus/ Graduated/ Assistant Professor, UCLA School of Social Work

Social Welfare/School of Social Work

TL1 Alumna/ Product Scientist, 23andMe

Neuroscience/ Dornsife College

[email protected]

Roberta Brinton, MA, PhD 323 442 1430 [email protected]

None

TL1 Alumna/Graduated/ Assistant Laboratory Technical Director, Ambry Genetics

Molecular Epidemiology

melissa.warden@ucsf. edu

Shahab Asgharzadeh, MD 323 660 2450 [email protected]

Roberta McKeanCowdin, MPH, PhD 323 865 0413 [email protected]

PhD

KL2 Alumna

Seattle Children’s Hospital

Pat Levitt, PhD 323 442 1509 [email protected]

Arthur Partikian, MD 323 409 3442 [email protected]

MD

KL2 Alumnus/ Associate attending/ Senior Research Fellow

Pediatrics/ Keck School of Medicine/ Children’s Hospital Los Angeles

[email protected]

David Warburton, MD, FRCP, FRCS 323 669 7075 [email protected]

David Freyer, DO, MS 323 361 8953 [email protected]

MD, MS

KL2 Alumnus/ Assistant Clinical Professor of Neurosurgery

Neurosurgery/ Keck School of Medicine

[email protected] [email protected]

Helena Chui, MD 323 442 7686 [email protected]

Caleb Finch, PhD 213 740 1758 [email protected]

MS, MD

KL2 Alumna/ Assistant Professor

Internal Medicine/ Keck School of Medicine

[email protected]

Tom Buchanan, MD [email protected]

Michael Goran, PhD 323 442 3027 [email protected]

MD, MSHS

KL2 Alumnus/ Assistant Professor

Internal Medicine/ Keck School of Medicine

MPH, PhD

BA, PhD Duration

Status / Rank

Cohort 1 Contact Information

MS, PhD

holloway@publicaffairs .ucla.edu

kimberly.aldinger@sea ttlechildrens.org

[email protected]

Michele Kipke, PhD 323 361 1875 [email protected]

Michael Gould, MD, MS C: 626 379 2648 W: 626 564 3926 [email protected]

Lawrence A. Palinkas, PhD 213.740.2711 [email protected]

None

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Cohort 2 Contact Information Award Type

Name/

TL1

Molly LancasterBrightman

Duration

7/1/11 – 7/1/13

TL1

Erik Serrao

Degree

Status / Rank

MA

TL1 Alumna/ Graduated/

BS, PhD Duration

7/1/11 – 12/1/12

TL1

Ahva Shahabi

Duration

7/1/11 – 7/1/13

TL1

Ryan Walker

Duration

7/1/11 – 6/30/12

KL2

Joyce Javier

Duration

7/1/11 – 7/1/14

KL2

Mimi Kim

Duration

7/1/11 – 7/1/14

KL2

Beth Pyatak

Duration

7/1/11 – 7/1/14

KL2

Douglas Vanderbilt

Duration

7/1/11 – 7/1/14

BS, MPH

TL1 Alumnus/ Graduated/ Postdoctoral Scholar, Internal Medicine, Harvard School of Medicine TL1 Alumna/ Graduated/ USC Research Lab Technician II

USC Department / School

Primary Mentor

Primary Mentor

Co-Mentor(s)

Preventive Medicine/ Keck School of Medicine

[email protected]

Jennifer Unger, PhD [email protected] 626 457 4052

Hooman Allayee, PhD [email protected] 323 442 1736

Pharmaceutical Sciences/School of Pharmacy

[email protected] rd.edu

Nouri Neamati, PhD [email protected] 323 442 2341

Andrea Kovacs, MD [email protected] 323 226 5068

Epidemiology Preventive Medicine/KSOM

[email protected]

Mariana C. Stern, PhD [email protected] 323 865 0811

Jacek Pinski, MD, PhD [email protected] 323 865 3929

Preventive Medicine/Keck School of Medicine

[email protected] m

Hooman Allayee, PhD [email protected] 323 442 1736

Wendy Mack, PhD [email protected] 323 442 1820

TL1 Alumnus/

MS, PhD

Graduated/NICHD Postdoctoral Research Training Program in Environmental Pediatrics, Charles Bronfman Institute for Personalized Medicine/ Mount Sinai Icahn School of Medicine

MD, MPH, MS

KL2 Alumna/ Assistant Professor

Clinical Pediatrics/ Keck School of Medicine/ Children’s Hospital Los Angeles

MD, MS

KL2 Alumna/ Assistant Professor

Pediatric Endocrinology/ Keck School of Medicine/ Children’s Hospital Los Angeles

MA, PhD, MS

KL2 Alumna/ Assistant Professor

Occupational Science & Therapy/ Ostrow School of Dentistry

[email protected]

MD, MS

KL2 Alumnus/ Assistant Professor

Clinical Pediatrics/ Keck School of Medicine/ Children’s Hospital Los Angeles

[email protected] du

[email protected]

[email protected]

Michele Kipke, PhD 323 361 8450 [email protected]

Mitchell Geffner, MD 323 361 7032 [email protected]

Florence Clark, MS, PhD 323 442 2113 [email protected]

Istvan Seri, MD, PhD 323 361 5932 [email protected]

Lawrence A. Palinkas 213 740 2711 [email protected] Jeanne Miranda, PhD 310 794 3710 [email protected] Steven Mittelman, MD, PhD 323 361 7653 [email protected] Mark Weigensberg, MD 323 442 3052 [email protected] Anne Peters, MD 310 657 3030 [email protected] Michele Kipke, PhD 323 361 8450 [email protected]

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Cohort 3 Contact Information Award Type

Name

TL1

Natalie Kintz

Degree

BA, PHD Duration

7/1/12 – 7/1/14

TL1

Mario Pulido

Duration

7/1/12 – 7/1/14

TL1

Lisa Yan

Duration

7/1/12 – 7/1/14

TL1

Megan Yardley

BSc, MSc, PhD

BSc, PhD

BSc, PhD Duration

7/1/12 – 7/1/14

KL2

Lilyana Amezcua

Duration

7/1/12 – 7/1/15

KL2

Lara Nelson

Duration

7/1/12 – 7/1/15

KL2

Johanna Olson

Duration

7/1/12 – 7/1/15

KL2

Gabriel Zada

Duration

7/1/12 – 7/1/15

Status / Rank

TL1 Alumna/ Graduated/ Graduate USC Research Fellow/Assistant

TL1 Alumnus/ Graduated

TL1 Alumna/ Graduated/Principal Quality Lab Associate, Baxalta

TL1 Alumna/ Graduated/ UCLA Post-doctoral Fellow

USC Department / School

Primary Mentor

Primary Mentor

Co-Mentor(s)

Neuroscience/ Dornsife College

[email protected]

Michael W. Jakowec, PhD 323 442 1057 [email protected]

Giselle Petzinger, MD 323 442 1057 [email protected] Daryl Davies, PhD 323 442 1427 [email protected]

Genetic Molecular and Cellular Biology/ Keck School of Medicine

[email protected]

Ite A Laird-Offringa, PhD 323 865 0655 [email protected]

Stephen Liu, MD 626 319 2130 [email protected]

[email protected]

W. Martin Kast, PhD 323 442 1711 [email protected]

Michael K Wong, MD, PhD 323 865 0314 [email protected]

[email protected]

Daryl Davies, PhD 323 442 1427 [email protected]

Stan Louie, PharmD 323 442 3646 [email protected] Michael Neely, MD 323 442 1300 [email protected]

[email protected]

Annette M. Langer-Gould, MD, PhD 626 564 3992 [email protected]

David Conti, PhD 323 442 3140 [email protected] Christopher J. L. Newth, MD 323 361 2117 [email protected] Leslie Clark, PhD 323 361 3917 [email protected]

Genetic Molecular and Cellular Biology/ Keck School of Medicine

Pharmacy & Pharmaceutical Sciences/ School of Pharmacy

MD, MS

KL2 Alumna/ Assistant Professor

Neurology/ Keck School of Medicine

MD

KL2 Alumna/ Assistant Professor

Pediatrics/ Keck School of Medicine/ Children’s Hospital Los Angeles

[email protected]

Jeffrey I. Gold, PhD 323 361 6341 [email protected]

MD, MS

KL2 Alumna/ Assistant Professor

Pediatrics-Adolescent Medicine/Keck School of Medicine/ Children’s Hospital Los Angeles

[email protected]

Marvin Belzer, MD 323 361 2112 [email protected]

KL2 Alumnus/ Assistant Professor

Neurosurgery/ Neuro-oncology/ Keck School of Medicine

MD, MS

[email protected]

Stephen Gruber, MD, PhD, MPH 323 865 0816 [email protected]

Co-mentors no longer at USC.

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Cohort 4 Contact Information Award Type

Name

TL1

Melissa Agnello

Duration

7/1/13 – 7/1/15

TL1

Dorsa Beroukhim Kay

Degree

Status / Rank

USC Department / School

BS, PhD

TL1 Alumna/ Graduated/ UCLA School of Dentistry Postdoctoral Fellow

Clinical and Experimental Therapeutics/ School of Pharmacy

BS Duration

7/1/13 – 7/1/15

TL1

Andrew Woodham

Duration

7/1/13 – 7/1/15

TL1

Jonathan Tucci

BA, PhD

BS Duration

7/1/13 – 7/1/15

KL2

Danieli Salinas

Duration

7/1/13 – 7/1/16

KL2

Alex Wong

Duration

7/1/13 – 7/1/16

KL2

Elizabeth Burner 7/1/13 – 7/1/16

KL2

Stefanie Bodison

Duration

7/1/13 – 7/1/16

TL1 Alumnus/ Graduated/ F32 Fellow Whitehead Institute TL1 Alumnus/ MD/PhD Student

Neuroscience/ Dornsife College

Genetics Molecular and Cellular Biology/ Keck School of Medicine

Endocrinology/ Keck School of Medicine

Primary Mentor

Co-Mentor(s)

[email protected]

Annie Wong-Beringer, Pharm D 323 442 1356 [email protected]

Steven Finkel, PhD 213 821 1498 [email protected]

[email protected]

andrew.woodham.phd@g mail.com

[email protected]

Rebecca Lewthwaite, PhD 562 401 6145 [email protected]. gov

Carolee Winstein, PhD 323 442 2903 [email protected] Pat Levitt 323 442 1509 [email protected]

W. Martin Kast, PhD 323 442 3870 [email protected]

Yvonne G. Lin-Liu, MD 323 442 7436 [email protected]

Steven Mittelman, MD, PhD 323 361 7653 [email protected]

Ernest Katz, PhD 323 361 5922 [email protected] David V. Conti, PhD 323 442 3140 [email protected] Duncan Thomas, PhD 323 4421567 [email protected] Wei Li, PhD 323 865 0618 [email protected] Yang Chai, DDS, PhD 323 442 3480 [email protected]

MD, MS

Assistant Professor

Pediatrics/Pediatric Pulmonology/ Keck School of Medicine/ Children’s Hospital Los Angeles

MD, FACS

Assistant Professor

Surgery/Plastic and Reconstructive/ Keck School of Medicine

[email protected] u

Young-Kwon Hong, PhD 323 442 7825 [email protected]

Emergency Medicine/ Keck School of Medicine

[email protected]

Sanjay Arora, MD 323 226 6667 [email protected]

Marjorie Kagawa-Singer, PhD 310 825 9481 [email protected]

Occupational Science and Occupational Therapy/ Ostrow School of Dentistry

[email protected]

Elizabeth Sowell, PhD 323 361 7347 [email protected]

Terence D. Sanger, MD, PhD 650 714 9475 [email protected]

MD, MS Duration

TL1 Alumna/ PhD Student

Primary Mentor

OTD, OTR/L

Assistant Professor of Clinical Emergency Medicine Research Assistant Professor

[email protected]

Thomas G. Keens, MD 323 361 2101 [email protected]

10

Cohort 5 Contact Information Award Type TL1

Name

Julie Jang

Duration

7/1/14 – 6/30/15

TL1

Elizabeth Siantz

Duration

7/1/14 – 6/30/15

TL1

Jordan Despanie

Duration

7/1/14 – 9/1/2014

TL1

Amber Angell

Duration

7/1/14 – 3/30/15

TL1

Brian Wu

Duration

9/1/2014-6/30/15

KL2

Mark Shiroishi

Degree

Status / Rank

USC Department/School

BSc, MD/PhD

TL1 Alumna/ Graduated/ Medical Resident

Integrative Biology of Disease/ Keck School of Medicine

BA, MSW, PhD

BSc

KL2

TL1 Alumna/ PhD Student

Social Work/ School of Social Work

PhD Student

Pharmacology and Pharmaceutical Science/ School of Pharmacy

[email protected]

[email protected]

Alan Epstein, MD, PhD 323 442 1172 [email protected]

Larry Palinkas, PhD 213 740 3990 [email protected]

John Andrew MacKay, PhD 323 442 4118 [email protected]

Clive Taylor, MD, DPhil 323 442 1215 [email protected] Eric Rice, PhD 213 821 4292 [email protected] Benjamin Henwood, PhD 213 821 6449 [email protected]

Peter Conti, MD, PhD 323 442 3858 [email protected]

Occupational Science and Occupational Therapy/ Ostrow School of Dentistry

[email protected]

Olga Solomon, PhD 323 442 2154 [email protected]

Larry Yin, MD, MSPH 323 361 8196 [email protected]

MD/PhD

TL1 Alumnus/ Graduated/ Medical Resident

Integrative Biology of Disease & Exercise Physiology/ Keck School of Medicine

[email protected]

E. Todd Schroeder, PhD 323 442 1515 [email protected]

Rick Hatch, PhD 323 442 5860 [email protected] Berislav Zlokovic, MD, PhD 323 442 2566

7/1/14 – 7/1/17

Assistant Professor

Neuroradiology/ Keck School of Medicine

[email protected] u

Meng Law, MD, MBBS, FRACR 323 442 7451 [email protected]

Sarah Rubin

7/1/14 – 7/1/17

Co-Mentor(s)

Graduated/Un of Chicago, IL Postdoctoral Fellow

MD Duration

[email protected]

Primary Mentor

BSc, MOT, OTR/L, PhD

MD Duration

Contact Information

Assistant Professor

Anesthesiology Critical Care Medicine-Pediatrics/ Keck School of Medicine/ Children’s Hospital Los Angeles

[email protected]

Christopher Newth, MD, FRCPC 323 361 2117 [email protected]

[email protected]

Arthur Toga, PhD 323 442 7246 [email protected] Russell Jacobs, PhD 626 395 2849 [email protected] Joshua Lee, MD 323 442 9529 [email protected] Yolanda Gill, PhD 323.448.8794 [email protected] Jeffrey Gold, PhD 323 361 6341 [email protected]

11

KL2

Christopher Russell

Duration

7/1/14 – 7/1/17

KL2

Greg Idos

Duration

7/1/14 – 7/1/17

MD

Assistant Professor

Pediatrics/ Keck School of Medicine/ Children’s Hospital Los Angeles

MD

Assistant Professor of Clinical Medicine

Division of Gastroenterology and Hepatology Keck School of Medicine

[email protected]

Michael Neely, MD, MSc 323 361 2509 [email protected]

[email protected]

Stephen Gruber, MD, PhD, MPH 323 865 0816 [email protected]

Christopher Newth, MD, FRCPC 323 361 2117 [email protected] Duncan Thomas, PhD 323 4421567 [email protected]

12

Cohort 6 Contact Information

Award Type

Name

KL2

Nathan Robison

Degree

MD Duration

Institutional Scholar

Duration

KL2

Duration

Institutional Scholar Duration

7/1/15 – 6/30/18

Status / Rank

Assistant Professor

Department / School

Division of Hematology, Oncology and Bone Marrow Transplantation, Department of Pediatrics, Children’s Hospital Los Angeles

Contact Information

Primary Mentor

Shahab Asgharzadeh, MD 323 361 8643 [email protected] [email protected]

Girish Dhall, MD 323 361 8147 [email protected]

Barbara Sargent

7/1/15 – 6/30/16

PT, PhD, PCS

Assistant Professor of Clinical Physical Therapy

Division of Biokinesiology and Physical Therapy, Herman Ostrow School of Dentistry

[email protected]

Carolee Winstein, PhD, PT, FAPTA 323 442 2903 [email protected]

PhD, OTRL

Assistant Professor

Division of Occupational Science and Occupational Therapy, Herman Ostrow School of Dentistry

[email protected]

Sharon Cermak, EdD, OTR/L, FAOTA 323 442 2879 [email protected]

Margaret Trost

7/1/15 – 6/30/18

Judith Villablanca, MD 323 361 5654 [email protected] Michael Neely, MD, MSc 323 361 2509 [email protected] Linda Fetters, PT, PhD, FAPTA 323 442-1022 [email protected] Bradley Peterson, MD 323 361 6496 [email protected] Natasha Lepore, PhD 310 909 3296 [email protected] Jeffrey Gold, PhD 323 361 6341 [email protected]

Leah Stein Duker

7/1/15 – 6/30/18

Co-Mentor(s)

MD, FAAP

Assistant Professor

Hospital Medicine, Pediatrics, Children’s Hospital Los Angeles

[email protected]

Maja Mataric 213 740 4520 [email protected]

Florence Clark, PHD, OTR/L, FAOTA 323 442 2113 [email protected] Ricky Bluthenthal, PhD 323-442-8236 [email protected] Jeffrey Gold, PhD 323 361 6341 [email protected] Sheree Schrager, PhD, MS 323 361 5727 [email protected]

13

Cohort 7 Contact Information

Award Type

Name

Institutional Scholar

Christine Azevedo

Duration

7/1/16 – 6/30/19

Institutional Scholar

Anoopindar Bhalla

Duration

7/1/16 – 6/30/19

KL2

Aaron Jensen

Duration

7/1/16 – 6/30/19

KL2

Ashwani Lakshmanan

Duration

7/1/16 – 6/30/19

Degree

Status / Rank

USC Department /School

Contact Information

Primary Mentor

Co-Mentor(s)

MD, MPH

Assistant Professor

Neurology, Keck School of Medicine

[email protected]

Daniel Pelletier, MD [email protected]

Arthur Toga, MD [email protected]

MD

Assistant Professor

Anesthesiology and Critical Care Medicine, Pediatrics, Children’s Hospital Los Angeles

[email protected] u

Christopher Newth, MD, FRCPC [email protected]

Anil Sapru, MD [email protected]

MD, MEd

Assistant Professor

Surgery, Pediatrics, Children’s Hospital Los Angeles

[email protected]

Jeffrey S. Upperman, MD [email protected]

MD, MPH

Assistant Clinical Professor

Neonatology, Pediatrics, Children’s Hospital Los Angeles

[email protected] .edu

Michelle Kipke, PhD [email protected]

Henri R. Ford, MD [email protected] Randall S. Burd, MD [email protected] Daniella meeker, PhD [email protected]

Roberta Williams, MD [email protected]

14

Scholar Resources As an CTR Scholar, you have access to the following: 

SC CTSI/WD Office Facilities: To request a consultation with any of the SC CTSI division’s below, please go to http://sc-ctsi.org/index.php/resouces/get_expert_advice.  Digital Innovation & Communications (DIC): This office provides a free, secure web-based application designed to support data capture and surveys for any research study called REDCap  Biostatistics, Epidemiology, and Research Design (BERD): Awardees may seek assistance in the following areas :  Study Design  Brief Biostatistical Consultation  Scientific Writing Support  Statistical Analysis  Research Development (RD): Awardees may seek assistance in the following areas:  Team development  Mock Grant Review  Community Engagement (CE): This office provides free services to awardees who are seeking:  Assistance with Research Design and Recruitment  Academic/community Matchmaking (to find the right academic or community partner for your project needs)  Assistance with Institutional Review Board (IRB) Application and Needs  Training on How to Conduct Community-engaged Research  Clinical Trials Unit (CTU)/ Clinical Research Support (CRS):  State-of-the-art space for the conduct of early phase (drug development) and complex mechanistic trials  Letter of support and preliminary budget for CTU-related services for grant applications  Design and feasibility consultation meetings o Meeting includes representation from CTU staff, clinical research expert(s), biostatistics, and informatics o Aim is to provide assistance with study design, feasibility and operational assessment, and protocol development  Data Safety and Monitoring Plan development assistance  Networking opportunities  Limited study coordinator and data management services for junior investigators or investigators with limited departmental resources  Clinical Data Services  Application Support for data management and data collection o Local Study Participant Discovery Tool (i2b2) o National Study Participant Discovery Tool (pSCANNER) o Los Angeles Data Portal (SHRINE) o Clinical Trials Management System (CTMS)  Infrastructure support to research community o Enterprise Research Data Warehouse (DEWARS) o LA Health Research Computing Cloud  Regulatory Knowledge and Support (RKS):  Advice on regulatory issues regarding medical product development, IDE and IND development o Educational offerings in regulatory science o Assistance with regulatory filings 15

 Conference Rooms: There are conference rooms shared with the Department of Preventive Medicine that maybe reserved through the WD office. Please contact WD Office at (323) 4428281 to reserve these rooms.  Internet: The Soto Building has USC wireless internet capabilities. You may login as a guest or use your assigned USC user name/password when prompted as you requesting access.  Journals: Medical Journals are available through the Norris Medical Library (http://www.usc.edu/hsc/nml/).  Parking: USC Health Science Campus Transportation Department is located on the first floor of the Keith Administration Building. Please check the website for parking permit information and possible locations to park (http://transnet.usc.edu/).  Clinical and Translational Research Training Video Library: http://www.sc-ctsi.org/workforcedevelopment/course-search#

 USC Core Facilities/Resources: The following are websites of other available resources or services at USC. You may find a comprehensive list of services at the SC CTSI website for your review (http://sc-ctsi.org/index.php/core/research_core_facilities).  Department of Animal Resources and the Institutional Animal Care and Use Committee (IACUC)- http://www.usc.edu/hsc/dar/  Biostatistics Core Services at (Norris) http://uscnorriscancer.usc.edu/Core/BioStats/  Statistical Consultation and Research Center (SCRC)http://keck.usc.edu/Education/Academic_Department_and_Divisions/Department_of_Preven tive_Medicine.aspx  Bioreagent and Cell Culture Core Facility (Norris)http://uscnorriscancer.usc.edu/Core/Bioreagent/  Cell Culture Core facility of the Liver Transplant Program and Center for Liver Diseasehttp://www.surgery.usc.edu/divisions/hep/research-cellculture.html  Flow Cytometry and Immune Monitoring Core (Norris)http://uscnorriscancer.usc.edu/core/Flow/  Epigenome Center Core Facilities- http://epigenome.usc.edu/  School of Pharmacy Histology Core Laboratory- http://pharmacyschool.usc.edu/  Cell and Tissue Imaging Core (Norris)- http://uscnorriscancer.usc.edu/core/Confocal/  Center for Electron Microscopy and Microanalysis (CEMMA)http://www.usc.edu/dept/CEMMA/  Molecular Imaging Center (USC MIC)http://keck.usc.edu/Research/Facilities_and_Resources/Imaging/Molecular_Imaging_Center.a spx  Resource Center for Medical Ultrasonic Transducer Technology- http://bme.usc.edu/UTRC/  Proteomic Core Facility- http://keck.usc.edu/Research/Centers_and_Programs.aspx  Translational Research Laboratoryhttp://pharmacyschool.usc.edu/research/infrastructure/translational/  Transgenic/Knockout Mouse Core Facility (Norris)http://uscnorriscancer.usc.edu/Core/Transgenic/  Lentiviral Core Facility- http://pharmacyschool.usc.edu/research/infrastructure/lentiviral/  Research Training Finder - http://researchtrainingfinder.usc.edu/ 

CHLA Core Facilities: The following are websites of other available resources or services at Children’s Hospital Los Angeles. You may find a comprehensive list of services at the SC CTSI website for your review (http://www.sc-ctsi.org/index.php/resources/core_facilities).  CHLA Biostatistics Corehttp://www.chla.org/site/c.ipINKTOAJsG/b.5915525/k.C27D/Biostatistics_Core.htm 16

 CHLA Fluorescence Activated Cell Sorting (FACS)http://www.chla.org/site/c.ipINKTOAJsG/b.3579495/k.544F/Fluorescence_Activated_Cell_Sor ting.htm  CHLA Genome Core http://genomecorechla.usc.edu/GenomeCore/Microarray/About_us.html  CHLA Good Manufacturing Practice Processing Facilityhttp://www.chla.org/site/c.ipINKTOAJsG/b.6055673/k.23F3/Good_Manufacturing_Practice_C ore.htm#services  Cellular Imaging Corehttp://www.chla.org/site/c.ipINKTOAJsG/b.3579487/k.927C/Cellular_Imaging.htm  Proteomics Core Facilityhttp://www.chla.org/site/c.ipINKTOAJsG/b.6053271/k.9506/Proteomics_Core.htm  Vector Core- http://www.chla.org/site/c.ipINKTOAJsG/b.6061503/k.8BAD/Vector_Core.htm 

Web-links of Interest  NIH Resources  NIH Institutes, Center and Offices – http://www.nih.gov  NIH Policies for New and Early Stage Investigatorshttp://grants.nih.gov/grants/new_investigators/index.htm  NIH Grants Announcements- http://grants1.nih.gov/grants/OER.htm  NIH RePorter- http://report.nih.gov  Updated Peer Review Process- http://enhancing-peer-review.nih.gov  Career Development Awardshttp://grants.nih.gov/traiing/careerdevelopmentawards.htm  NIH Loan Repayment Programs- http://www.lrp.nih.gov  Grant Writing Tips- http://grants.nih.gov/grants/grant_tips.htm  Inside the NIH Grant Review Processhttp://cms.csr.nih.gov/ResourcesforApplicants/InsidetheNIHGrantREviewProcessVideo.htm  Agency for Healthcare Research and Quality- http://www.ahrq.gov  ClinicalTrials.gov- http://clinicaltrials.gov  National Center for Advancing Translational Sciences- http://ncats.nih.gov/  NIH-DHHS Loan Repayment Program: NIH wants to encourage outstanding health professionals to pursue careers in biomedical, behavioral, social, and clinical research. If you commit at least two years to conducting qualified research funded by a domestic nonprofit organization or U.S. federal, state, or local government entity, NIH may repay up to $35,000 of your qualified student loan debt per year, including most undergraduate, graduate, and medical school loans. Loan repayment benefits are in addition to the institutional salary you receive for your research. For info: http://www.lrp.nih.gov/  Other Clinical and Translational Research Resources  eRA Commons and Other Features- http://era.nih.gov  Online Writing Lab- Sponsored by Purdue University- http://owl.english.purdue.edu/owl  UpToDate- http:www.uptodate.com/home/index.html  Coriell Personalize Medicine Collaborativehttp://www.coriell.org/index.php/content/view/92/167  Personalized Medicine Coalition- http://www.personalizedmedicinecoalition.org  Pharmacogenomics Knowledge Base- http://www.pharmgkb.org

17

Academic Calendar The CTR Program comprises of the following activities: 1) didactic coursework 2) seminar sessions 3) workin-progress 4) annual progress report and 5) abstract submission for possible oral or poster presentation at the annual CTSA conference. As part of NIH reporting requirements, attendance will be taken. Program Coursework WD has developed new Clinical Translational Research courses (CTR 1-3) to be given under the Department of Preventive Medicine. These courses will provide an overarching understanding and view of research from the clinical translational perspective. Using a new teaching and instructional method, the courses are taught in a problem-based fashion that requires Scholar engagement and participation. Elements include: 1) 2) 3) 4) 5)

Brief lecture for approximately 15-20 minutes, An example/problem and solution, In-class group exercise, Individual or group homework, and Presentation of the homework.

As a required component to the program, each Scholar must register and complete each of the courses (13) before leaving the CTR program for credit (total 12 units). If you are obtaining a certificate in Clinical, Biomedical, and Translational Investigations you will need to take a minimum of 6 months (3 units) of practical research experience on a research project (PM590/790). Each course is offered consecutively each semester as indicated below: Course Name Principles of Biostatistics (PM510L)* Responsible Conduct of Research (INTD500)*+

Semester Summer 2016 Summer 2016

Course Duration May 2016 – August 2016

Units 4

This one week course is to be completed during the course of the summer if not already done. August 1–8, 2016

1

Clinical Translational Research Course 1 (PM612a)

Fall 2016

August 23, 2016 – December 13, 2016 (Every Tuesday – 1-5pm)

4

Clinical Translational Research Course 2 (PM612b)

Spring 2017

January 10, 2017 – May 9, 2017 (Every Tuesday – 1-5pm)

4

Clinical Translational Research Course 3 (PM612c)

Summer 2017

May 18, 2017 – June 29, 2017 (Every Tuesday and Thursday – 1-5pm)

4

Directed Research (PM590)/Special Topic (PM790)

Fall 2016Fall 2017

To be completed anytime during the course of the year.

3

*Recommended coursework for summer semester prior to registering for CTR1.

+



Required by NIH RCR training requirements for postdoctoral research scholars. Dates are subject to change. Schedule will be finalized August 2016.

Please note WD highly recommends the course in Principles of Biostatistics (PM510L) during summer semester prior to taking CTR1. This will enable much greater understanding of the materials discussed in Clinical Translational Research 1(Fall Semester). Per National Institute of Health, Responsible Conduct of Research training is required for postdoctoral research scholars paid from federal contracts and grants having a component of ethical training.

18

You may enroll online for the courses by going to http://www.usc.edu/dept/ARR/registration/procedures.html and follow the instructions provided. Career Development Seminar Sessions (CDSS) These seminar sessions are intended to assist in developing various CTR competencies that include collaborative approaches to learning, leadership, scientific, and communication skills. Seminar session formats will vary from year to year and include: 1) journal club: review or original articles will be sent out prior to each seminar session for reading and will be discussed during the session, 2) Career Development Session: an invited guest will present a brief lecture and discussion will follow, and 3) Work-in-progress: trainees present latest update on research and/or career development. A senior CTR Scholar maybe asked to help facilitate any of these types of sessions. Sessions take place on a monthly basis on specified dates and locations from 3pm-5pm. Majority of these sessions are strictly for CTR Scholars. Please refer to seminar session under the schedule section. Work-in-Progress Approximately every six months, all CTR Scholars provide an update on their research. A work-in-progress will occur in place of a seminar session topic. This will be a 10-15 minute presentation of your research to the group of CTR Scholars and mentors with a 5 minute question and answer period. All mentors must attend this meeting. WD will request to meet with mentors after each Work-in-Progress or on an as needed basis to go over the CTRs progress. Annual Progress Report The CTR Scholar must provide a written annual progress report which is a review of the benchmarks that were met for the mentoring, education, and research plans. This report will be submitted every June. As the due date nears, Scholars will receive detailed instructions on completing the progress report. Submission of the completed progress report is an absolute condition of the CTR award. Lastly, WD will request to meet with each individual Scholar and/or mentor each June/July to review their overall progress for the year. Annual Translational Science Meeting All CTR Scholars are expected to attend and to present their research at the CTSA conference in the first year of their program. As a representative of USC’s SC CTSI, this three or four-day meeting presents an exceptional opportunity to meet and interact with key clinical research leaders from NIH, to hear and read about multidisciplinary clinical research from other CSTA awarded institutions, promote professional, career networking, and to form collaborative partnerships in multidisciplinary clinical research. 

All CTR Scholars will attend the Translational Science Meeting in Washington, DC in April.

Each CTR Scholar will submit an abstract based on their research in collaboration with their mentor(s). This abstract will be presented to the CTR peers and the WD Leadership. Upon abstract acceptance, posters and oral presentations must use a structured poster or slide presentation template provided by WD. These templates will be sent electronically at the time of formal acceptance notification. WD expects everyone to be present at their poster presentations for the duration of their designated time. We encourage fellow peers to attend these poster and oral presentations. A member from the WD Leadership will attend each of the conferences.

19

Prior to Completion of CTR Appointment/Program Upon completion of the program, the following components must be fulfilled:     

Submission of final progress report on the status of mentoring, educational, and research plans; A CTR and mentor meeting with WD Leadership for final review and evaluation of CTR Scholar progress; Final mentor and mentee evaluation submitted to WD; Submission of a K series grant application (e.g., K23/K08): Scholars are expected to apply for an individual K23/K08 award (or other career development award) to replace the CTR. The K23/K08 could extend the total duration of K funding, and establish the Scholar as a PI with contacts at NIH. Submission of updated CV and NIH Biosketch.

Post Completion of CTR Appointment As part of NIH reporting, WD must track all CTR Scholars for 10 years after the completion of their appointment. CTR Scholars will be contacted to provide an updated CV annually, and to complete an Alumni Survey form. Please provide the WD office updated contact information on an as needed basis.

20

WD’s TRAINING PROGRAM AND ACADEMIC CALENDAR Dates

June 30, 2016 July 30, 2016

TASKS THROUGHOUT THE TRANING PROGRAM

CTR

Responsibilities MENTOR(S)

Completed 

PRE-REQUISITE Orientation Session x x Provide all required documentation to J. Dzekov McKean ([email protected]): x x  Mentor/Mentee Interaction Form x  Commitments as a Mentee/Terms of the Award Contract x  Commitments as a Mentor(s) as Terms of the Award Contract x  Budgets/Budget Justification for CTR Scholar x x  Satellite Account Commitment (Only for (Only for Form signed by CTR Scholar, USC CTR USC CTR Mentor & CTR Scholar’s Awardees) Awardees) Department Administrator x  IRB/IACUC Research Approval Letter, and Amendment Approval Letter (if amended since application process) x x  CITI Human Subjects Training or ICUC Training Certificate x  CITI Conflict of Interest Training Certificate x  Certificate of Financial Disclosure form (https://disclose.usc.edu) x  Certificate of Completion of Department of Contracts and Grants Management Education through the Office of Compliance (http://ooc.usc.edu/grantsmanagement-educationprogram) x  Revised Research abstract (250 words) x  Revised NEW format Biosketch to include award information and Section A. Personal Statement x  Brief biography (5-7 sentences in length)  Copy of Clinical Research Protocol (if amended since application process) 21

WD’s TRAINING PROGRAM AND ACADEMIC CALENDAR Dates

TASKS THROUGHOUT THE TRANING PROGRAM  Informed Consent Document/Assent Document  Product information such as clinical investigator brochure, package insert, or description of the device (if clinical trial is proposed)  Documentation of IND/IDE has been obtained or letter from FDA that study is IND-exempt or IDE has been waived (if clinical trial is proposed)  A new or revised “Protection of Human Subjects” section for the pilot or K scholar project that (A) clearly describes the risk, protections, benefits and importance of the knowledge to be gained by the revised or new activities (as required in the Notice of Award and detailed in “Part II: Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan” of the NIH competing application instructions), and (B) clearly identifies the information relevant to CTR Scholar project.  Inclusion Plans for Women, Minorities, and Children  Targeted Enrollment Table or Inclusion Data Record (IDR)  Data and Safety Monitoring Plan (DSMP)/Data Monitoring Oversite Plan  Response to Reviewer’s Comments (by September 30, 2016) Apply to MS/Certificate in Clinical and Biomedical Investigations

Responsibilities CTR MENTOR(S)

Completed 

x x

x

x

x x x

x

x

(Contact: Roland Rapanot – [email protected])

August 30, 2016

Watch Online WD Media Studio Catalog Video on “The Art of Mentorship and Being Mentored” (E. Bogenmann)

x

x

22

WD’s TRAINING PROGRAM AND ACADEMIC CALENDAR Dates

TASKS THROUGHOUT THE TRANING PROGRAM

Responsibilities CTR MENTOR(S)

Completed 

(Login required: http://scctsi.org/index.php/workforcedevelopment/course/the-art-ofmentorship-and-being-mentored)

Summer Semester 2016 (YEAR 1 OF THE PROGRAM BEGINS) May 2016 Registration for Summer Course(s): Classes begin May 2016 – August 2016



Principles of Biostatistics (PM510L)

x

August 1–8, 2016



Responsible Conduct of Research (INTD500) or CHLA Course Equivalent

x

(Note: If you have already completed this requirement, please provide WD office with documentation.)

July 1, 2016

Award Appointment Begins

x

x

(Note: Please begin to spend your award monies)

July 4, 2016 Fall Semester 2016 August 15, 2016 – August 19, 2016

Independence Day (Holiday) Registration for Fall Course(s)  Clinical Translational Research 1 (PM612a)  Directed Research (PM590)/Special Topics (PM790) (Note to CTRs: If you have already taken this type of course, please speak with Roland Rapanot to see if it could be applied towards your MS or Certificate.)

x x (For CTRs, this may be taken in the nd 2 year.)

August 23, 2016 – December 13, 2016 (Every Tuesday 1pm-5pm in SSB301) September 5, 2016 Date/Time/ Location: TBA

Clinical Translational Research 1 (PM612a) Begins

September 14, 2016 (3-5pm)

Career Development Seminar Begins Topic: Baseline Research Presentations

x

Complete Online Progress Update Questionnaire for SC CTSI’s NIH

x

Location: USC-HSC, 1450 Biggy Street, Norris Research Tower (NRT) Lower Ground Level, Aresty LG503-504, Los Angeles, CA 90089

October 2015 – November 2015

x

Labor Day (Holiday) Attend 2-hour In-person Mentoring Workshop

x

x

st

(This 1 day required attendance)

23

WD’s TRAINING PROGRAM AND ACADEMIC CALENDAR Dates

TASKS THROUGHOUT THE TRANING PROGRAM

Responsibilities CTR MENTOR(S)

Completed 

Annual Progress Report October 3, 2016 (3-5pm)

Career Development Seminar

x

Location: Harkness Auditorium

October 14, 2016 (9am-5pm)

WD’s Short Course in Research in Diverse Urban Populations

Location: Aresty LG503/504

November 16, 2015 (12:00PM-1:00PM)

x (Required attendance)

Research Ethics Forum

x

CTRs work on abstracts for Annual Translational Science Meeting Career Development Seminar

x

Location: Aresty LG503-504

November 2016 – December 2016 November 14, 2016 (3-5pm)

x

x

Location: Harkness Auditorium

November 23 – 27, 2016 December 5, 2016 (2-4pm)

(4-5pm)

Thanksgiving (Holiday) CTR Work-in-Progress

x (CTRs Present Research)

CTR Mentor Meeting

x (CTR Mentors Mandatory Attendance)

x

Location: Harkness Auditorium

December 3 – 6, 2016 December 13, 2016

Study Days

x

Clinical Translational Research 1 (PM612a) Exam Winter Recess

x

December 15, 2016 – January 8, 2017 Spring Semester 2017 January 2017 WD Leadership provides CTRs feedback on conference abstract WD Leadership provides mentors with CTR fall semester progress report CTR along with their mentor(s) meet with WD Leadership: 6-month Progress Review January 10, 2017 Clinical Translational Research 2 (PM612b) Classes Begin January 5 – 6, 2017 Registration for Spring Course(s):  Clinical Translational Research 2 (PM612b) January 23, 2017 Career Development Seminar

x x

x

x

x

(Mandatory Attendance)

(Mandatory Attendance)

x x

x 24

WD’s TRAINING PROGRAM AND ACADEMIC CALENDAR Dates

TASKS THROUGHOUT THE TRANING PROGRAM

Responsibilities CTR MENTOR(S)

Completed 

(3-5pm) Location: Harkness Auditorium

January 16, 2017 February 15, 2016 (3-5pm)

Martin Luther King’s Birthday (Holiday) Career Development Seminar

x

Location: NTT7409

February 20, 2017 March 2017

President’s Day (Holiday) CTR work on poster and oral presentations for Translational Science Meeting 2017 March 12 – 19, 2017 Spring Recess March 27, 2017 (3-5pm)

x

Career Development Seminar

x

WD Leadership provides feedback to CTRs on poster for CTSA Conference Translational Science Meeting 2017 (Washington Marriott Wardman Park in Washington, DC) Career Development Seminar

x

Clinical Translational Research 2 (PM612b) Course Ends Study Days

x

Location: Harkness Auditorium

March 27, 2017 – April 7, 2016 April 18 – 21, 2017

April 24, 2017 (3-5pm)

x

x

Location: Harkness Auditorium

April 25, 2017

April 29, 2017 – May 2, 2017 May 9, 2017 Clinical Translational Research 2 (To Be Confirmed) (PM612b) Final Exam Summer Semester 2017 May 15 – 16, 2017 Registration for Summer Course(s):  Clinical Translational Research 3 (PM612c) May 18, 2017 – Clinical Translational Research 3 June 29, 2017 (PM612c) Begins May 22, 2017 Career Development Seminar (3-5pm)

x x

x

x x

Location: Harkness Auditorium

May 29, 2017 May 2017 – July 2017

Memorial Day (Holiday) Complete Online Annual Progress Report

June 26, 2017 (2-4pm)

CTR Work-in-Progress

x

x (CTRs

x (CTR Mentors

25

WD’s TRAINING PROGRAM AND ACADEMIC CALENDAR Dates

TASKS THROUGHOUT THE TRANING PROGRAM

Responsibilities CTR MENTOR(S) Present Research)

(4-5pm)

CTR Mentor Meeting

Completed 

Mandatory Attendance)

x

Location: Harkness Auditorium

June 12, 2017

Potential NIH K Series grant NEW submission(s) July -August 2017 CTR and their mentor(s) meet with (Dates TBA) WD Leadership: 12-month Progress Review July 1, 2017 Begin NIH xTrain Appointment Process Online July 4, 2016 Independence Day (Holiday) July – August 2016 WD Leadership will provide feedback on the 12-month Progress Review meeting Fall Semester 2017 (YEAR 2 OF THE PROGRAM) September 4, 2017 Labor Day (Holiday) September 2017 Career Development Seminar (Monthly seminars Sessions Begin 3pm–5pm) TBA October 2017 – Complete Online Progress Update November 2017 Questionnaire for SC CTSI’s NIH Annual Progress Report October 12, 2017 November 12, 2017

November 22 – 26, 2017 December 14, 2017 – January 8, 2017

Potential NIH K Series grant NEW submission(s) Potential NIH K Series grant RESUBMISSION/REVISIONS submission(s) Thanksgiving (Holiday)

x x

x

(Mandatory Attendance)

(Mandatory Attendance)

x

x

x

x

x

x x

Winter Recess

26

Policies, Procedures, Requirements, and Expectations for CTR Scholars Terms of CTR Award Please review this booklet along with your mentor(s) and your department coordinator. Please indicate you and your primary mentors understanding and acceptance by signing and returning the “Terms of the Award” document found at the end of this handbook. Please return this form which due by August 31, 2016. NIH xTrain Appointment Process xTrain is a web-based program that allows NIH users to electronically process and track appointment forms for awardees/trainee as well as eliminates the need for signed paper forms. The xTrain interface is also used by NIH Electronic Research Administration (eRA) Agency. WD representative will initiate the awardee’s training appointment within the xTrain system which then routes the Appointment Form (2271) to the Trainee. The Trainee the xTrain to complete the form and route it back to the WD with his/her electronic signature. A similar process is used again at the end of a Trainee’s Appointment with a Termination Notice. Setting up eRA Commons Account If you already have an account, the Trainee role will be added, and you will be asked to update your Personal Profile. Please note that all demographic information must be completed and is not an optional requirement: Otherwise, Trainee appointment will not be processed. If you do not have an eRA Commons account, the xTrain system will automatically send you an email with a link and instructions for registering Commons as part of the Appointment or Termination process. Please enter information in all the text fields as this may delay your appointment process especially those marked with an asterisk (*). Then click Continue.

In the provided file, enter comments (if needed) and then click Continue Account Request. 27

Click Complete Account Request to complete the account request process.

You will receive an email within 2-5 days indicated that your account is active. Creating eRA Commons Personal Profile Each eRA Commons account has an associate Personal Profile screen that includes information specific to the account holder. Personal profile information is used to pre-populate appointment and termination forms in xTrain. The xTrain system will check to ensure that you have provided all the necessary information prior to routing your xTrain forms back the WD representative. Once an xTrain Trainee account is created the Trainee must log into eRA Commons and access each of the trainee’s specific Personal Profile pages to provide the information needed to populate the xTrainrelated forms. xTrain will check the Trainee’s Profile during the Appointment/Termination process and will generate Errors/Warnings if expected information is not provided or conflicts with NIH policies for the designated type of appointment. In order to complete the Personal Profile successfully, please enter as much of the information in each of the tabs listed under the Personal Profile tab:    

Personal Information Race/Ethnicity Residential Address Degrees/Residency 28



Trainee Specific

Please note that if you do not enter any information in these fields, your appointment process will be delayed until completed.

Process New Appointments on xTrain-Trainee Instructions A WD representative will initiate the appointment process in xTrain. This is an example of the appointment process flow:

Trainee users are brought to the Trainee Appointments and Terminations screen when the xTrain tab is selected. Click the Process 2271 link to access the Appointment form. The 2271 form is opened and pre-populated with information pulled from the Trainee Profile and previously entered by the WD Representative.

29

If applicable, please select the appropriate Specialty Boards and indicate if enrolled in a dual-degree program.

Prior Kirschstein-NRSA Support information is pulled from the profile if you had prior career development awards from NIH. To correct or update this information, go to Admin/Account/Verify NIH Support and enter a grant number. It is here, that you should review the remaining information on the form and contact WD Office with any concerns. If time does not permit, you may click Save at any time and complete the form later if you need be. Once completed, please click Save and Route to PI to continue the Appointment process.

30

The system will validate the information contained in the 2271 form and will flag any Errors or Warning found. Errors must be corrected before the Appointment is routed. Warnings are corrected at your discretion.

Optional comments (up to 2000 characters) can be included in e-mail message to PD/PI/WD Representative. Once any comments have been entered click Continue.

The Route to PI Confirmation screen will record your electronic signature when you click I Accept.

Click Done to finish. xTrain will then change the Appointment status to In Progress PI.

An WD representative will complete the appointment process and will submit the 2271 form to the Agency. Please note, the Agency may accept the appointment, place it on hold, hold it for a paper signature, delete it, view the PDF file, or route it back to the Institution. The WD Office will inform you of final appointment acceptance. Please note that WD will not be able to dispense award funds until

31

xTrain Appointment has been has been accepted/approved by the Agency. Also, it may take 30 days or longer for NIH Appointment approval/acceptance. Additional xTrain information can be found on the xTrain support page at http://era.nih.gove/services_for _applicants/other/xTrain.cfm. xTrain Web-Based Training materials can be found at http://era.nih.gov/virtualschool/external/class_xtrain.htm Users may also request assistance from the eRA Commons Help Desk: eRA Commons Help Desk Web: http://ithelpdesk.nih.gov/eRA/ Toll-free: 1-866-504-9552 Phone: 301-402-7469 TTY: 301-451-5939 Hours: Mon-Fri, 7:00am to 8:00pm Eastern Time IRB/IACUC Approval CTR Scholars are required to provide the WD Office a copy of their current Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) approval letter for your research project within 60 days of your award notification. Having IRB approval is not a condition of dispensing research funds, but having submitted for IRB review is. If you are having difficulty with the regulatory submission process, please contact the WD Office if guidance or assistance is needed. Notification of Adverse Events to National Center for Advancing Translational Sciences (NCATS) NCATS Program Officer for SC CTSI should be notified of all adverse events in clinical studies supported by NCATS resources that are serious, unexpected and related to participation in research. As required by federal regulations, NCATS must be notified of all unanticipated problems, as outline by OHRP guidance (see www.hhs.gov/ohrp/polic/adventiguid.html), on studies supported by an NCATS grant. This does not preclude or impact other reporting requirements to other entities (e.g., OHRP). Please send your adverse event notification to: National Center for Advancing Translational Sciences National Institutes of Health 6701 Democracy Blvd, Bethesda, MD 20892-4874 (use 20817 for express shipments) Also, please send WD with a copy of your adverse event report via email to [email protected]. Program Commitment and Percent Effort The CTR award requires at least 75% protected time to be spent in clinical research and training activities. Please be aware of the required activities during your appointment. Moonlighting is not encouraged based on the level of commitment necessary for a successful training program. Please notify the WD Office immediately if you would like to resign, take a leave of absence, or decrease your percent effort to less than 75%, but no less than 50% protected time if sufficiently justified and programmatically appropriate. In order to appropriately justify any exceptions, please provide the following information in a letter from you and your mentors:    

Memo describing the request and justification Clarify if there is other support (especially NIH funding support), Expand upon the justification as to why the desired percentage clinical time is not sufficient to retain skills, Provide a detailed listing of your weekly schedule prior to CTR appointment, and 32



Delineate and provide a brief explanation of your responsibilities prior to CTR appointment.

WD Leadership will review the letter. Should WD Leadership concur, then the Principal Investigator (Thomas Buchanan, MD) will submit this information along with a letter which will be countersigned by an appropriate USC institutional official to the National Center for Advancing Translational Sciences (NCATS). Please note it may take up to 6 months for NCATS to approve or reject this request. Core Didactic Coursework and Training Scholars are expected to obtain a Master of Science in Clinical, Biomedical, and Translational Investigations offered through the Keck School of Medicine. Scholars are responsible for following academic requirements and remain in good standing within the degree program. Failure to do so will adversely affect CTR status. You are expected to be enrolled in the translational research courses, and attend the seminar sessions and work-in-progress sessions as well. The annual CTSA Conferences are required attendance. WD Program Evaluations WD is always trying to improve our programs and contribute to the national CTSA consortium. We will regularly ask for your feedback to evaluate the program and inquire about experience as a CTR Scholar at the entrance to the program, 6-months, 12-months, 18-months, and 24-months. These evaluations are mandatory for all scholars and mentors. All data collected via interviews and questionnaires at each time point will be used for program evaluation purposes only. Attendance Scholars are expected to attend all courses, program activities, and scheduled events. Please note that attendance will be taken and tracked. We expect that you come to all sessions and if necessary notify us one week prior to the event of your absence. Clinical Privileges Scholars are encouraged to maintain clinical privileges through their respective clinical departments (not to exceed 25% effort) in order to retain clinical privileges. Calendar and Holiday Schedule The program will observe the official university holiday schedule (unless otherwise notified). A program calendar has been provided for you in the previous section. Vacation and Other Time Away Submit vacation and leave plans to the WD office for pre-approval if conflicts with program activities arise, especially the Annual CTSA Translational Science Conference in Washington, DC each April. Parental Leave Scholars may continue to receive salary/stipend support for up to 60 calendar days (8 weeks) of parental leave per year for the adoption or birth of a child. Either parent is eligible, but the parental leave must be pre-approved by the WD Leadership. Using parental leave will not extend the duration of the CTR appointment. Department Clearance (d-Clearance) If course section number ends in "D" (ex: 410245D) you must request Departmental Clearance. The dclearance process ensures that students have completed the required pre-requisites or passed placement examinations. You must get D-clearance for the course before you register. Contact the home department coordinator to obtain d-clearance and provide at least the following information: 1.) 2.)

Name USC 10-digit number 33

3.) 4.)

Course section number Contact information (phone number or email address)

Please note it may take up to 48 hours to process d-clearance in some departments. If you need to obtain d-clearance for Clinical Translational Research 1-3 courses, please contact Jeanne Dzekov McKean, Program Administrator, who is the designated Home Department Coordinator at (323) 4428281 or dzekov.usc.edu. Registration Procedure for Course as Limited Status Employee (USC Employees Only) Staff employees may receive tuition assistance for two types of coursework. Degree candidates who are formally admitted to the university may receive up to 100% tuition assistance for a maximum of six units per semester, of which no more than four units may be at the graduate level. A staff employee who is not formally admitted to the university may take one work-related course for audit per semester with his or her supervisor’s certification that the course is work-related. Tuition assistance will be provided to full-time faculty members for auditing on course per semester, or for a limited number of units of coursework taken for credit in undergraduate, graduate, or professional classes per semester or summer session. However, faculty members shall not be candidates for degrees in the same school in which they have an appointment and, in addition, assistant professors on the tenure track should not simultaneously be candidates for degrees anywhere at the university. Individual exceptions may be made only with the approval of the Provost or of a special committee appointed by the President. Please refer to http://benefits.usc.edu/files/2014/07/this-form-to-Benefits.pdf to complete this form. All requests for tuition assistance must be submitted with the appropriate documentation. Please contact directly or proceed to the UPC benefits office with questions. Benefits Administration is located at 3720 S. Flower Street 2nd floor, Credit Union Building, Room 200, Los Angeles, CA 90089-0704, Phone: (213) 740-6027, Fax: (213) 740-3875, [email protected]. The WD office or Roland Rapanot will provide assistance with this process for those who are seeking to complete the MS in Clinical, Biomedical, and Translational Investigations. Please follow these steps to register for a course as a limited status USC employee. 1. 2. 3.

4. 5. 6. 7.

Fill out the Limited Status-Pre Admission form: http://benefits.usc.edu/files/2014/07/this-form-toBenefits.pdf Fill out the Graduate Coursework Certification form: http://ais-ss.usc.edu/empldoc/forms/Tuition_Grad_form_060612.pdf. Fill out the Limited Status Registration form: http://benefits.usc.edu/files/2014/07/this-form-to-theRegistrars-office.pdf Proceed to the department coordinator (Jeanne Dzekov McKean-WD Program Administrator for CTR1-3 courses only) at the department where you’ll be taking the class. Obtain Dclearance by providing the department coordinator your USC 10-digit ID number, name, and course section number. Obtain signature on the appropriate forms. Go back to your home department. Obtain signature from your supervisor/department chair on the appropriate forms. Fax form #1 to UPC Benefits Office at (213) 740-3875. Proceed to UPC Registration Department at 601 Exposition Blvd., Los Angeles, CA 90089-0912 to turn in form #3 in person. Precede to HSC Payroll Department in the Parkview Medical Building A, Room 300, 1420 San Pablo Street, PMB-A300, MC 9050, Los Angeles, CA 90089-9050 to turn in form #2 in person.

This is merely for the registration process, but there are subsequent steps to take relating to health insurance, additional fees not covered by employee benefits, and Blackboard access. Please note these instructions are not provided on any website, but have been provided to WD Office through various scholar experiences. Should you need further assistance, contact the WD Office at (323) 442-4039.

34

Tuition Remission Process if Accepted into the MS Program Once officially accepted into the MS Program in Clinical, Biomedical, and Translational Investigations, these are steps you must follow to obtain tuition remission:

2.

1. Registration process must be completed. Print out and complete the tuition remission form entitled “APPLICATION FOR TUITION ASSISTANCE FACULTY.” To obtain the form, please visit: http://benefits.usc.edu/files/2014/07/TAB_Faculty.pdf 3. Dr. Judy Garner, Vice Provost for Faculty Affair, will need to sign the form. Her office is in KAM 110 (phone number: 323-442-1619; fax: 323-442-1992) and you can submit the form to Robin Kaufman. 4. Once the form is signed, After, Robin Kaufman will submit it to UPC Benefits Administration (Campus mail to CUB 200 OR Fax to 213-740-3875) on your behalf. PLEASE NOTE: REGISTRATION AND COMPLETION OF THE TUITION REMISSION FORM IS DONE EVERY SEMESTER!

Promotions and Annual Salary Merit Increases Appointments to the faculty or any type of promotions are acceptable, but the amount of salary support paid to the department/divisions will not be increased beyond the amount as stated in the application process. The original terms of the award will stay the same. Please notify the WD Office of any change in your employment status as part of our tracking and evaluation process. If faculty are promoted into an administrative position and are given an administrative stipend for those extra duties, SC CTSI/WD will not be able to support that portion of the salary. SC CTSI/WD will honor any annual salary merit increases within the NIH cap (of $200,000). International Research International research experiences will be considered on a case-by-case basis, but prior approval is required for any Scholar or Trainee who wishes to conduct research overseas. To request approval, submit a letter with the described mentoring plan for the international research experience, detailed justification for the international research, including the reasons why the facilities, the mentor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. You along with your mentors must sign this letter and submit it for WD Leadership review. Should WD Leadership concur, then the Principal Investigator (Thomas Buchanan, MD) will submit this information along with a letter which will be countersigned by an appropriate USC institutional official to the National Center for Advancing Translational Sciences (NCATS). NCATS will submit all documentation for approval to the NIH Fogarty International Center. You will need to complete a separate copy of Form NIH 1820 for each country involved in the project. Please note it may take up to 6 months for NCATS to approve or reject this request. Citations for Grant Support or Publication All publication, press releases or any other documents that cite results from NIH-supported research must include acknowledgements of NIH grant funding and a disclaimer such as: 



NIH-funded Clinical and Translational Scholars: This work was supported by grant KL2TR001854 from the National Center for Advancing Translational Science (NCATS) of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Institutionally-funded Clinical and Translational Scholars: This work was supported by grant UL1TR001855 from the National Center for Advancing Translational Science (NCATS) of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. 35

Obtaining PMCID Number for All Publications NIH now requires all investigators to upload into the PubMed Central database all papers accepted for publication after April 1, 2008. This is a separate database from PubMed. PubMed assigns each paper a PMID number, and PubMed Central a PMCID number. You are required to include, in competing/noncompeting grant applications as well as in your biosketch and CVs while in this training program, the PMCID on all references to your work that resulted from NIH support. N.B. this applies to papers accepted for publication after April 1, 2008; you don’t have to do this for older papers. For a long list of FAQ and the official response refer to http://publicaccess.nih.gov/FAQ.htm#c9. Also, you may watch SC CTSI/Norris Medical Library videos on the process at http://scctsi.org/index.php/workforce-development/course/pubmed-tutorial. Some journals deposit the paper automatically. For those journals it may be weeks or a year before a PMCID is available. You need to put the following in the PMCID field: PMCID: PMC Journal - In Process For a list of the journals that submit for you, please refer to the following website: http://publicaccess.nih.gov/submit_process_journals.htm. Please note you will probably not be assigned a PMCID for weeks, or maybe not until the article is released in a year. In the meantime, NIH requires you to list the NIHMSID. You may want to enter this in the EndNote label field when you load the mss. It is recommended to have your EndNote database available, and when you enter each paper copy the NIHMSID number into the label field for the reference. A video on how an investigator can request a PMCID can be found here: Submitting an Article to PubMed Central (http://publicaccess.nih.gov/PAMRevised082608.wmv)

STEP 1: Log into NIHMS using eRA commons, NIH Login or My NCBI. (If using My NCBI login, login to My NCBI website in order to access NIHMS.) STEP 2: In NIHMS follow instructions for manuscript submission. You will need author’s name, journal name, article title, manuscript files and grant/project numbers. STEP 3: Ensure that you cite the CTSA grant as a source of support. STEP 4: The publication will receive an NIHMSID until the time in which the publication has been approved and uploaded to PubMed Central. (SC CTSI program staff can use the NIHMSID instead of the PMCID on the Data Section if the PMCID is not yet available.) STEP 5: Author receives an e-mail from NIH and follows the link provided to approve the PMC-formatted Manuscript for Public Display. This occurs 2-3 weeks after STEP 3. STEP 6: After completion of STEP 5 a PMCID will be assigned • NIHMS will email the author and all PIs the citation with the PMCID • PMC will automatically make the paper publicly available after the designated delay period has expired.

Sexual Harassment Hotline Information, counseling, referral or other assistance regarding the university’s sexual harassment policy or concerns about sexual harassment in the classroom or workplace is available by contacting the Office of Equity and Diversity at 213-740-5086. You may review policy and procedures at http://policies.usc.edu/policies/complaint/sexharassment070108.pdf. Student Loans Deferred Please contact your Academic Coordinator or the financial aid office for your degree program for signature approval or more information on any student loan deferments. 36

Tax Documentation As university policy WD is not able to provide you with tax guidance pertaining to your award. Should your award conflict with your student loan or financial aid, please contact the financial aid office for assistance, and/or consultant your own tax consultant regarding such matters. Disability Services The University has mechanisms in place to assist students with disabilities. Please contact the Disability Services and Programs (attn.: Director: Edward Roth, Ph.D./Associate Director, Mattie E. Grace, Ph.D.) at (213) 740-0776/(213) 740-6948 (TDD only), or at [email protected]. They are located at University of Southern California, Student Union 301, Los Angeles, CA 90089-0896. Please refer to their website for further assistance at http://sait.usc.edu/academicsupport/centerprograms/dsp/home_index.html.

37

CTR Scholar Support Due to new requirements from NIH, the Southern California Clinical and Translational Science Institute (SC CTSI) has restructured the funding mechanism for the CTR Scholar Program (previously KL2 and ICD Program). Under the new program, all scholars can participate in the CTR program for three years with funding. Resources for each scholar’s participation in the program will be provided as follows: 1) Salary Support: Each scholar must devote 75% effort to the CTR program, unless approved to participate at a lower percentage by SC CTSI and the NIH. Salary support will be provided at the scholar’s effort with the CTR program, up to the NIH cap and not to exceed $120,000 plus fringe benefits. 2) Research Support: Each scholar will be awarded up to $25,000 annually for tuition and research related expenses. Please refer to the Scholar’s handbook for details on spending policies. Funding for each scholar’s appointment is provided by the SC CTSI and the scholar’s home department. The timing of contributions from each source differs from year to year for each scholar. Please refer to your financial letter for a summary of the funding source for your appointment. The program is committed to support a minimum of 4 Scholars per year throughout the five year period of the Clinical Translational Science Award. Subsequent program continuation will depend on NIH renewal of the institutional CTSA. All award amounts are subject to change depending on SC CTSI funding.

USC/CHLA CTR Awardees: A subaward for the Scholars salary, fringe and research support will be issued to CHLA for each year of the program. CTR Research Related Expenses and Tuition CTR Scholars will receive up to $75,000 in total ($25,000 each year for each year in the program) for research costs, travel or tuition. Research Related Expenses We expect that scholars will receive resources in support of research activities from mentors and departments/divisions as indicated in the CTR application. A listing of (un)allowable research related costs under the CTR award are provided below and are based on NIH submission guidelines. Allowable Research Related Costs:  Laboratory or office supplies  Clinical supplies  Long distance telephone charges  Shipping charges  Clinical lab costs  Equipment costing less than $5000  Patient travel, honoraria, and care costs: Participant fees/incentives are allowed. Please keep a detailed log of all costs and how the money is dispensed towards inpatient/outpatient costs or if multiple sites are used. This will be needed for NIH auditing purposes.

38

   



   

Personnel costs: The CTR Program does not allow for new full-time positions to be created using CTR funds, as these positions are not sustainable beyond the duration of scholar award. Consultant costs: A detailed justification requesting these funds is required, describing the services to be performed, the number of hours of anticipated consultant (and duration), the expected rate of compensation, and any travel, per diem and other related costs. Computer and software costs Domestic travel for research up to $5,000 in Year 1: Costs may be used to cover hotel, transportation, meeting registration, food, and printing of poster presentation for any other research related travel costs (must be essential for achieving project objects); and/or attending other scientific meetings. A portion of travel stipend (approximately $2500) must be used to cover hotel, transportation, meeting registration, food, and printing of poster presentation for the Translational Science Meeting in Washington, DC in April 2017 (mandatory attendance in first year of training to this conference.) Domestic travel for research up to $2,500 in Year 2 and 3: Costs may be used to cover hotel, transportation, meeting registration, food, and printing of poster presentation for any other research related travel costs (must be essential for achieving project objects); and/or attending other scientific meetings. Outside coursework Mini-sabbatical experiences: This requires strong documentation, justification, and endorsement by the primary mentor. Please submit all documentation for WD Leadership review and approval. Other educational or career development experiences Required/recommended textbooks, materials and software

Unallowable Research Related Costs:  A proposal to hire full-time staff  Foreign travel or foreign research expenditures (requiring prior NIH approval)  Equipment costing over $5000: NIH definition is of equipment is as follows: “An article of tangible nonexpendable personal property that has a useful life of more than 1 year and an acquisition cost per unit that equals or exceeds the lesser of the capitalization threshold established by the organization or $5000. The $5000 limit on equipment includes necessary modifications, attachments, etc., which make is usable for the purpose for which it is acquired or fabricated.  Late fees, fines and graduation charges  Alteration and renovations: Repairs, painting, removal/installation of partitions, shielding, air conditioning etc. or other costs for alterations and renovations are not allowable for these pilot research projects. Disallowed charges become the responsibility of the scholar’s department/division. Developing a Budget & Budget Justification Prior to receiving these funds, xTrain appointment process must be approved by NIH/NCATS for NIHfunded scholars. All CTR Scholars must submit a budget and budget justification which should reflect the first year of the scholar’s appointment. Our forms are a modified version of the PHS 398 and 2590 forms, which are used for almost all NIH or other federal agency grant applications. The budget justification is a detailed narrative explanation of the proposed research project expenses for each category required to achieve project aims and objectives. This document must be included with the proposed budget when submitted to the WD Office. The justification explains and makes sense 39

of the budget so scholars should strive to show as much detail as possible. Each item listed in the budget must be clearly justified. A detailed budget justification demonstrates a thorough and careful approach to the project. Important elements to include in the budget justification are the anticipated expenses, description of the expenses, how they relate to (and benefits) the project and the time period in which these expenditures would take place. Estimate these expenses realistically and show where you got your figures-break it into components, then explain each component. In general, the budget justification should:  Provide as much detail and justification as necessary  Follow the order of the detailed budget page  Provide additional details about significant items  Explain why each of the items on the budget page is needed to accomplish the CTR proposed research  Include tuition costs in “OTHER EXPENSES” category on the detailed budget page, and provide information on which courses, units for each, and the intended semester the CTR Scholar will take during the first year of the program. The money allocated (of $25,000) for tuition and research expenses will need to be spent each year by May 31st .  Make sure requests are reasonable and consistent with CTR Program, USC/CHLA, and NIH policies A sample budget and budget justification is enclosed for you to complete. Spending milestones for each year: Seventy-five percent (75%) of these funds must be expended by March 30, 2017 in Year 1. In Year 2, fifty percent (50%) of funds must be expended by January 30, 2018 and seventy-five present by March 30, 2018. If the spending does not meet the milestone timeline indicated, these funds could be taken away and allocated to other Scholars. All unused funds as of May 31st of each fiscal are not eligible for carryover or “encumbered” beyond the end of the year. Please contact the WD Office for clarification on budget distribution policy.

40

SC CTSI/WD CTR SCHOLAR YEAR 1 BUDGET CTR Scholar Name: Project Title: DETAILED BUDGET FOR INITIAL BUDGET PERIOD DIRECT COSTS ONLY

FROM

THROUGH

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME

ROLE ON PROJECT

Cal. Mnths

Acad. Mnths

Summer INST.BASE Mnths SALARY

SALARY REQUESTED

FRINGE BENEFITS

TOTAL

PD/PI

SUBTOTALS CONSULTANT COSTS EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

TRAVEL

INPATIENT CARE COSTS OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

CONSORTIUM/CONTRACTUAL COSTS

DIRECT COSTS

SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 7a, Face Page) CONSORTIUM/CONTRACTUAL COSTS

TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD

$

FACILITIES AND ADMINISTRATIVE COSTS

$

PHS 398 (Rev. 6/09)

41

SC CTSI/WD CTR SCHOLAR YEAR 1 BUDGET CTR Scholar Name: Project Title:

BUDGET JUSTIFICATION

GRANT NUMBER

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary.

CURRENT BUDGET PERIOD

FROM

THROUGH

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget.

PHS 2590 (Rev. 06/09)

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Tuition CTR Scholars may register for the required courses (e.g., Clinical Translational Research Courses 1-3) by enrolling online at https://www.usc.edu/admission/graduate/applyonline/ and following the instructions provided. The cost per unit is $1, 666. For enrolling in all three courses (12 units), approximate cost for tuition will be $19,992. The cost for the completion of the MS is approximately $48,314. Please note that required/recommended textbooks, materials and software must be paid from Scholar’s research funds. USC CTR Awardees Receiving Research Related Expenses/Tuition Funds: Upon appointment process approval and having obtained your budget/budget justification, WD will complete a Satellite Establishment Form so that the money may be accessed by the CTR Scholar, primary mentor, and the Scholar’s home department administrator through this satellite account. Please have your departments/division financial administrator keep detailed documentation of all purchases. You will need to provide an excel spreadsheet as a financial progress report of all expenses including tuition costs, copy of all receipts, proof of delivery paperwork, and ASRs to WD for NIH auditing purposes on a quarterly basis. Should unallowable charges or if overdraft on this account, the CTR Scholar’s department/division will be held responsible. Please provide CS CTSI/WD another departmental account so that CS CTSI financial personnel may transfer those expenses. These are the following documentation needed by SC CTSI and NIH to establish a satellite account: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

11. 12. 13. 14. 15. 16. 17. 18. 19. 20.

Brief biography (5-7 sentences in length) Revised Biosketch to include CTR Award and Section A. Personal Statement Revised CTR research abstract (250 words) Copy of Clinical Research Protocol (if amended since application process) IRB/IACUC Research Approval Letter, and Amendment Approval Letter (if amended since application process) CITI Human Subjects or IACUC Animal Training Certificate Informed Consent Document/Assent Document Product information such as clinical investigator brochure, package insert, or description of the device (if clinical trial is proposed) Documentation of IND/IDE has been obtained or letter from FDA that study is IND-exempt or IDE has been waived (if clinical trial is proposed) A new or revised “Protection of Human Subjects” section for the pilot or K scholar project that (A) clearly describes the risk, protections, benefits and importance of the knowledge to be gained by the revised or new activities (as required in the Notice of Award and detailed in “Part II: Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan” of the NIH competing application instructions), and (B) clearly identifies the information relevant to CTR Scholar project. Inclusion Plans for Women, Minorities, and Children Targeted Enrollment Table or Inclusion Data Record (IDR) Data and Safety Monitoring Plan (DSMP)/Data Monitoring Oversite Plan Mentee/Mentor Interaction Form Commitment of Mentee/CTR Scholar - Terms of CTR Award Commitment of CTR Mentor(s) - Terms of CTR Award Certificate of Financial Disclosure: https://disclose.usc.edu Certificate of Completion of Department of Contracts and Grants Management Education (Office of Compliance: http://ooc.usc.edu/grants-management-education-program) Response to Reviewer Comments (by September 30, 2016) The detailed budget and budget justification as described on pages 38-41 of the handbook for research related expenses/tuition. 43

21. The CTR Scholar, Primary Mentor, and Scholar’s Administrator must sign the following form acknowledging the comprehension of this information as well as providing departmental account number in case of overdraft:

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Satellite Account Commitment Form (Note: Not Applicable to CHLA Awardees)

I have read and understood the allowable/un-allowable charges as stated as part of tuition/ research related expenses in the Mentored Career Development (CTR) Informational Handbook. If an overdraft on this account occurs, my department (____________________________________) will be responsible for those charges to my Department Name satellite account. Please use the following departmental account number _______________________________________ in case of overdraft on my satellite account.

________________________________________________ Signature of CTR Scholar / Date

_______________________________________________ Signature of CTR’s Primary Mentor / Date

________________________________________________ Administrator for CTR Scholar / Date

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The cost of tuition should be paid through the satellite account. Please incorporate tuition as part of the financial progress report as instructed previously. However, should you decide to use the majority of your funds for research related expenses, CTR Scholars who are USC employees/full-time faculty may enroll in the Translational Research Courses 1-3 using their USC employee or full-time faculty benefits. For more information for Registration of Courses as Limited Status Employee (for USC Employees Only), please refer to the Policy and Procedure section for step-by-step instructions. CHLA CTR Awardees Receiving Research Related Expenses/Tuition Funds: SC CTSI will create a subcontract with CHLA which will include research related expenses and tuition. Upon appointment process approval, these are the following documentation needed by SC CTSI and NIH to dispense funding: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

11. 12. 13. 14. 15. 16. 17. 18. 19. 20.

Brief biography (5-7 sentences in length) Revised Biosketch to include CTR Award and Section A. Personal Statement Revised CTR research abstract (250 words) Copy of Clinical Research Protocol (if amended since application process) IRB/IACUC Research Approval Letter, and Amendment Approval Letter (if amended since application process) CITI Human Subjects or IACUC Animal Training Certificate Informed Consent Document/Assent Document Product information such as clinical investigator brochure, package insert, or description of the device (if clinical trial is proposed) Documentation of IND/IDE has been obtained or letter from FDA that study is IND-exempt or IDE has been waived (if clinical trial is proposed) A new or revised “Protection of Human Subjects” section for the pilot or K scholar project that (A) clearly describes the risk, protections, benefits and importance of the knowledge to be gained by the revised or new activities (as required in the Notice of Award and detailed in “Part II: Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan” of the NIH competing application instructions), and (B) clearly identifies the information relevant to CTR Scholar project. Inclusion Plans for Women, Minorities, and Children Targeted Enrollment Table or Inclusion Data Record (IDR) Data and Safety Monitoring Plan (DSMP)/Data Monitoring Oversite Plan Mentee/Mentor Interaction Form Commitment of Mentee/CTR Scholar - Terms of CTR Award Commitment of CTR Mentor(s) - Terms of CTR Award Certificate of Financial Disclosure: https://disclose.usc.edu Certificate of Completion of Department of Contracts and Grants Management Education (Office of Compliance: http://ooc.usc.edu/grants-management-education-program) Response to Reviewer Comments (by September 30, 2016) The detailed budget and budget justification as described on pages 38-41 of the handbook for research related expenses/tuition.

Please indicate on the detailed budget and budget justification paperwork all courses and total number of units to be taken during the program. However, should you decide to use the majority of your funds for research related expenses, CTR Scholars who are USC/CHLA full-time faculty may enroll in the Translational Research Courses 1-3 using their USC employee or full-time faculty benefits. For more information for Registration of Courses as Limited Status Employee (for USC Employees Only), please refer to the Policy and Procedure section for step-by-step instructions (pages 32).

46

Please have your departments/division financial administrator keep detailed documentation of all purchases. You will need to provide an excel spreadsheet as a financial progress report of all expenses including tuition costs, copy of all receipts, proof of delivery paperwork, and ASRs to WD for NIH auditing purposes on a quarterly basis. All CTR Awardees: Please contact STA Travel at (213) 254-2664 for flight arrangements especially for the CTSA Conference. Inform STA Travel to send your flight itinerary and costs to Jeanne Dzekov McKean, WD Program Administrator, at [email protected] for payment processing. Please submit all other travel, hotel, registration, and food reimbursement to Wendy Rosero, Finance Manager, SC CTSI Finance Office (at [email protected]) for direct reimbursement.

47

Mentee and Mentor Requirements As the mentee (CTR Scholar) and the respective mentoring team, there are certain expectations and commitments that need to be fulfilled during the CTR program. On the next few pages there are a set of documents that must be reviewed by the mentee and his/her mentors as a group, require signatures, and resubmission to WD Office at by July 30, 2016. Mentor/Mentee Interaction Form Before completing this form electronically, the mentee should make additional copies of this document. The mentee and each mentor must complete the form individually, and then jointly review and discuss each person’s answers in order to reach an agreement. Please note that some of these questions may reflect what has already been submitted under the mentoring plan. The mentee must re-write the agreed upon answers before the form is signed and dated by him/her and each mentor. The mentee is responsible for keeping this form and reviewing/updating it as necessary. WD must be provided an updated version of the form should changes be made at any time. This form will be used as part of WD’s mentor and mentee evaluation process for the duration of the program. Commitments/Terms of CTR Award for the Mentee and Mentor(s): This contract serves both as a pledge and a reminder to mentors and their CTR Scholars that their conduct in fulfilling their commitments to one another should reflect the highest professional standards and mutual respect.

48

Mentor/Mentee Interaction Form* 1. What type of assistance does the mentee want from the mentor? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ 2. What expectations do the mentors have of the mentee? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ 3. What expectations does the mentee have of the mentors? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ 4. How often will you meet? ___________________________________________________________________________________ ___________________________________________________________________________________ 5. When and where will you meet? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ 6. For how long? ___________________________________________________________________________________

From the University of Alabama-Birminham CTSI Application Form

49

7. Who will be responsible for scheduling the meetings? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ 8. What will meeting topics include? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ 9. What will be the ground rules for discussions? (E.g., confidentiality, openness, candor, truthfulness, etc.) ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ 10. If problems arise, how will they be resolved? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ 11. Any concerns the mentee wants discussed and resolved? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________

From the University of Alabama-Birminham CTSI Application Form

50

12. Any concerns the mentors want discussed and resolved? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ 13. How will you know when the mentoring relationship has served its purpose and needs to be terminated? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ 14. We have agreed that our initial meetings will focus on these three topics: a._________________________________________________________________________________ b._________________________________________________________________________________ c._________________________________________________________________________________ 15. Any additional areas/issues you want to discuss and agree to? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ Signatures: __________________________________________ Mentee Signature

_________________ Date

__________________________________________ Primary Mentor Signature

_________________ Date

__________________________________________ Co-Mentor Signature

_________________ Date

__________________________________________ Other Mentor Signature

_________________ Date

From the University of Alabama-Birminham CTSI Application Form

51

Contract of Commitments/Terms of the CTR Award for the Mentee and Mentor(s) Contract between CTR Scholar, Their Mentors, and SC CTSI/WD Postdoctoral training is an integral component of the preparation of scientists for career advancement as scientific professionals. CTR Scholar training is conducted in an apprenticeship mode where she/he works under the supervision of an investigator who is qualified to fulfill the responsibilities of a mentor. The CTR Scholar may undertake scholarship, research, service, and teaching activities that together provide a training experience essential for career advancement. Core Tenets of CTR Training Quality CTR Training Individuals should be trained to independently formulate meaningful hypotheses, design and conduct interpretable experiments, adhere to good laboratory practices, analyze results critically, understand the broad significance of their research findings, and uphold the highest ethical standards in research. The development of additional skills—including oral and written communication, grant writing, and laboratory management—are considered integral to this training. Importance of Mentoring in Postdoctoral Career Training Effective mentoring is critical for postdoctoral career training and requires that the primary mentor and co-mentors dedicate substantial time to ensure personal and professional development. A good mentor builds a relationship with the trainee that is characterized by mutual respect and understanding. Attributes of a good mentor include being approachable, available, and willing to share his/her knowledge; listening effectively; providing encouragement and constructive criticism; and offering expertise and guidance. Foster Breadth and Flexibility in Career Choices CTR Scholar must have training experiences of sufficient breadth to ensure that they are prepared to pursue a wide range of professional career options. Effective and regular career guidance is essential and should be provided by the mentor and the institution. Terms of the CTR Award Upon acceptance of the award, CTR Scholar and their mentors are required to attend and participate in the Work-in-Progress, Annual Review Process, and mentor/mentee workshops, and other events scheduled by WD.

Revised version of the Compact for Postdoctoral Appointees Association of American Medical Colleges

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Commitments as a Mentee/CTR Scholar as Terms of the CTR Award  I acknowledge that I have the primary responsibility for the development of my own career. I recognize that I must take a realistic look at career opportunities and follow a path that matches my individual skills, values, and interests. • I will follow our well-defined goals and timelines for my research project under the guidance of my mentor.  I will commit 75% protected time to be spent in clinical research and training activities. • I will perform my research activities conscientiously, maintain good research records, and catalog and maintain all tangible research materials that result from the research project. • I will respect all ethical standards when conducting my research including compliance with all institutional and federal regulations as they relate to responsible conduct in research, privacy and human subjects research, animal care and use, laboratory safety, and use of radioisotopes. I recognize that this commitment includes asking for guidance when presented with ethical or compliance uncertainties and reporting on breeches of ethical or compliance standards by me and/or others. • I will show respect for and will work collegially with my coworkers, support staff, and other individuals with whom I interact.  With the assistance of my primary mentor and co-mentors, we will implement a mutually agreed upon mentorship and educational plan with final approval from WD Leadership. • I will endeavor to assume progressive responsibility and management of my research project(s) as it matures. I recognize that assuming responsibility for the conduct of research projects is a critical step on the path to independence. • I will seek regular feedback on my performance and ask for a formal evaluation as stipulated under the CTR Program requirements. • I will have open and timely discussions with my mentor concerning the dissemination of research findings and the distribution of research materials to third parties.  I will acknowledge the support and disclaimer by citing the SC CTSI and National Center for Advancing Translational Sciences (NCATS) in any publication, abstract, or presentation as stipulated in the handbook.  I will forward any intra- or extra-mural award, publication, abstract, and presentation information to the CS CTSI’s Workforce Development. • I recognize that I have embarked on a career requiring “lifelong learning.” To meet this obligation I must stay abreast of the latest developments in my specialized field through reading the literature, regular attendance at relevant seminar series, and attendance at scientific meetings. Revised version of the Compact for Postdoctoral Appointees Association of American Medical Colleges

53

• I will actively seek opportunities outside the laboratory (e.g. professional development seminars and workshops in oral communication, scientific writing, and teaching) to develop the full set of professional skills necessary to be successful for my chosen career.  At the end of my appointment, in accordance with institutional policy, I will leave behind all original notebooks, computerized files, and tangible research materials so that other individuals can carry on related research. I will also work with my mentor to submit the research results for publication in a timely manner. I can make copies of my notebooks and computerized files, and have access to tangible research materials which I helped to generate during my postdoctoral appointment according to institutional policy.  I will attend and participate in all CTR program required Translational Research Courses 1-3, Career Development Seminar Sessions (CDSS), Work-in-Progress, progress meetings (at 6-, 12-, 18-, and 24months), mentee workshops and other event(s) as stipulated by WD.  I will attend the annual Translational Science Meeting in the 1st year of the CTR Program.  I will complete the required elements in order to obtain the Masters of Science or Certificate in Clinical, Biomedical, and Translational Investigations (CBTI).  I am aware and responsible for my primary mentor and co-mentors to attend WD mandatory mentor related events which include Work-in-Progress, progress meetings (at 6-, 12-, 18, and 24months), mentoring workshops, and other event(s) as stipulated by WD.  I will submit my annual progress report and final progress report in a timely manner.  I will complete all mentor evaluations as required.  I will submit a K23/K08/R01 application upon the completion of CTR program.  I will continue to assist the WD in the tracking my progress after the completion of the CTR program by submitting my CV and NIH Biosketch annually.  I will assist in mentoring other CTR Scholars, students, and staff while I am in the program.  I will uphold the academic integrity and USC’s policy on plagiarism.  I confirm that I have read this CTR Handbook.

__________________________________________ Mentee/CTR Scholar Signature

_________________ Date

Revised version of the Compact for Postdoctoral Appointees Association of American Medical Colleges

54

Commitments as CTR Mentor(s) as Terms of the CTR Award  I acknowledge that the CTR period is a time of advanced training intended to develop the skills needed to promote the career of the CTR Scholar. • I will ensure the CTR Scholar has 75% protected time to be spent in clinical research and training activities. • I will ensure that a mutually agreed upon set of expectations and goals are in place at the outset of the CTR training period, and I will work with the CTR Scholar to adhere to the individual career development plan. • In collaboration with the CTR Scholar and his/her co-mentors, we will implement a mutually agreed upon mentorship and educational plan with final approval from WD Leadership.  I am aware and will ensure as a mentor to attend the WD mandatory mentor related events which include Work-in-Progress, CTR Scholar progress meetings (at 6-, 12-, 18, and 24-months), mentor workshops, and any other event(s) stipulated by WD. • I am aware and will ensure as a mentor that the CTR Scholar will complete the MS in Clinical, Biomedical, and Translational Investigations (CBTI).  I am aware, as well, will ensure as a mentor that the CTR School receives my assistance and will submit a K or R grant application upon the completion of the CTR program.  I will strive to maintain a relationship with the CTR Scholar that is based on trust and mutual respect. I acknowledge that open communication and periodic formal performance reviews, conducted at least annually, will help ensure that the expectations of both parties are met. • I will promote all ethical standards for conducting research including compliance with all institutional and federal regulations as they relate to responsible conduct in research, privacy and human subjects research, animal care and use, laboratory safety, and use of radioisotopes. I will clearly define expectations for conduct of research in my facility and make myself available to discuss ethical concerns as they arise. • I will ensure that the CTR Scholar has sufficient opportunities to acquire the skills necessary to become an expert in an agreed upon area of investigation. • I will provide the CTR Scholar with the required guidance and mentoring, and will seek the assistance of other faculty and departmental/institutional resources when necessary. Although I am expected to provide guidance and education in technical areas, I recognize that I must also educate the postdoctoral appointee by example and by providing access to formal opportunities/programs in complementary areas necessary for a successful career. • I will provide a training environment that is suited to the individual needs of the CTR Scholar in order to ensure his/her personal and professional growth. I will encourage a progressive increase in the level of responsibility and independence to facilitate the transition to a fully independent career. Revised version of the Compact for Postdoctoral Appointees Association of American Medical Colleges

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• I will encourage the interaction of the CTR Scholar with fellow scientists both intra- and extramurally and encourage the Scholar’s attendance at professional meetings to network and present research findings. • I will ensure that the research performed by the CTR Scholar is submitted for publication in a timely manner and that she/he receive appropriate credit for the work she/he performs. I will acknowledge her/his contribution to the development of any intellectual property and will clearly define future access to tangible research materials according to institutional policy.  I recognize that there are multiple careers options available for an CTR Scholar and will provide assistance in exploring appropriate options. I recognize that not all CTR Scholar will become academic faculty. To prepare an CTR Scholar for other career paths, I will direct her/him to the resources that explore non-academic careers, and discuss these options. • I will commit to being a supportive colleague to the CTR Scholar as they transition the next stage of their career and to the extent possible, throughout their professional life. I recognize that the role of a mentor continues after the formal training period.  I confirm that I have read this CTR Handbook.

__________________________________________ Primary Mentor Signature

_________________ Date

__________________________________________ Co-Mentor Signature

_________________ Date

__________________________________________ Other Mentor Signature

_________________ Date

Revised version of the Compact for Postdoctoral Appointees Association of American Medical Colleges

56