POSITION DESCRIPTION

Job title:

Research Nurse

Work Unit:

Bay of Plenty Clinical School

Responsible to:

Clinical School Research Manager

Position purpose:

Completion of activity associated with clinical research trials in the Clinical Trials Unit. Liaising with sponsoring companies, clinical staff, and patients, to assist with recruitment and patient safety.

Date:

18 December 2015

Organisational context

CEO

Academic Coordinator/ Head of BOP Clinical School

Clinical School Business Leader

Education Manager

RHIP Student Placement Coordinator E-Learning Facilitator

Career Development Advisor Administration Support

Librarians

Student Placement Coordinator

Research Manager

Research Proposal Coordinator

Medical Speciality Advisor Year 6 Clinical Training Coordinator (UoA)

Research Nurses Clinical School Coordinator

Clinical School Administrator

PGY 1/2 Clinical Training Coordinator Allied Health Student Training Coordinator Student Clinical Training Coordinators (UoA) CLINICAL LEADS

Simulation Technician

The Bay of Plenty District Health Board: The District Health Board’s fundamental purpose it to work within the resources allocated to it to improve, promote and protect the health of the whole population within its district, and to promote the independence of people with disabilities. Vision: Mission: Values:

Key Outcomes:

Healthy, thriving communities Enabling communities to achieve good health and independence and ensure access to high quality services. C Compassion A Attitude R Responsiveness E Excellence Improved health and independence for children and families Healthy, independent and dignified aging Improved Maori health and independence to reduce disparities Improved access and inclusiveness Effective, responsive health programmes

Functional relationships Internal:

External:

Clinical School staff BOP DHB Medical, Nursing & Allied Health Staff

Study Coordinators Drug Companies Clinical Research Organisations Device Companies

Principal accountabilities The Research Nurse reports to the Research Manager and is responsible for the administration and management of allocated clinical trials. She/he also assists and supports the Research Manager with day to day running of the Clinical Trials Unit (CTU), and assumes some of the Research Manager responsibilities when she/he is away. The Research Nurse encompasses the following major functions or key achievement areas:  Undertaking allocated pharmaceutical/device studies for the Bay of Plenty Clinical School Clinical Trials Unit  Managing studies on a daily basis including co-ordination with other Study Co-ordinator/s  Coordinating/undertaking original research studies

Health and Safety You are expected to meet the health and safety requirements set out in BOPDHB policies and protocols and any other requirements set out in the Health and Safety in Employment Act 1992.

Treaty of Waitangi/Cultural Competencies BOPDHB is committed to the principles of the Treaty of Waitangi

The Bay of Plenty District Health Board is a smokefree environment

Note The performance standards are provided as a guide only. The precise performance measures for this position will need further discussion between the jobholder and manager as part of the performance development process.

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Key achievement areas The position of Research Nurse encompasses the functions or Key Achievement Areas broadly identified below: 1. Pharmaceutical/Device studies Utilises clinical research nursing skills to proactively manage participants within Clinical Trial Protocols.

2. Compliance with Regulatory Requirements

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Utilises nursing and research knowledge to provide clinical expertise and case management for participants within the research protocol guidelines.

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Reviews and critiques trial protocols, clarifying any potential issues with standard of care and identifying solutions.

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Actively participates in all activities leading up to site initiation and trial commencement including, but not limited to: Co-ordinating Ancillary services - Pathlab, other Specialists, Sub Investigators etc. as appropriate for the study.

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Investigator/Coordinator Meetings are attended as appropriate.

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Identifies potential participants and assesses eligibility so that recruitment targets for studies that the jobholder is responsible for are met within the timeframe agreed with the sponsor. Recruitment template is completed and reviewed regularly to ensure milestones are met.

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Ensures informed consent is obtained from participants before any trial related activity occurs.

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Co-ordinates all study related procedures such as phlebotomy, ECG’s, questionnaires and ensures all activities are conducted as per the protocol, Standards of Procedure and Good Clinical Research Practice.

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Storage and administration of study related medications supplied by the study as per protocol to ensure participant safety.

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Ensures Case Report Forms are completed as per trial requirements.

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Data is collected and entered within the timeframe required by the sponsor either using paper case record forms or electronic case record forms. Source data worksheets are created if not supplied by the sponsor.

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All queries for allocated trials are completed within the timeframe required by the sponsor.

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The jobholder coordinates and is available for Trial Monitors as appropriate and responds to outstanding issues in the timeframe required by the sponsor.

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In the absence of the Research Manager the Research Nurse also completes feasibility studies.

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Ensure Clinical Trials are conducted within ICH/GCP guidelines.

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Assists with Ethics and Regulatory applications and ensures: - Locality assessment and Maori consultation are obtained. - If lead site for a study, undertaking online Ethics Applications.

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3. Financial and Administrative related to Clinical Trials

4. Original Research Studies

5. General Tasks

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Ensures all Adverse Events and Serious Adverse Events are reported within the timeframes as per contract / protocol.

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Liaises with Sponsor, Principle Investigator to ensure that all regulatory documents are obtained, updated and stored appropriately.

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Provides input into the development and maintenance of the study budget.

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Research Subject information is supplied to the Research Assistant promptly; Study Alerts, Referrals, Encounter forms, PICs, GP letters etc.

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Accurate time-keeping and allocation of study hours on electronic timesheets is completed.

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Input of all study appointments into shared diary is completed in a timely manner.

The following is completed as appropriate:     

Patient recruitment, follow up and assessment Input with protocol development Ethics committee submissions Design of Case Report Forms Creation, data entry and analysis of databases

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Rostered team duties as required are performed ie. Temperature monitoring, resus trolley check. If unable to complete, nurse arranges cover.

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Completion of all DHB required Courses such as Health and Safety Treaty Training, Customer Service etc. and any required professional competencies updated.

Person specification Qualifications/ Knowledge / Experience Essential:  Is a Registered Nurse with a current practising certificate  Is able to prioritise and manage competing demands  Has proven administration skills & ability to develop and maintain excellent systems  Has excellent record management skills (electronic and paper records)  Is competent in the use of all MS Office applications  Is competent in the use of MS Access or other databases  Meets deadlines  Maintains confidentiality  Displays attention to detail  Is able to organise, coordinate and support  Has excellent communication skills (verbal and written) Desirable  Has previous experience in a health research role  Has knowledge of the BOPDHB, its structure, services and staff

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Key Behaviours: All BOPDHB staff are measured against the following Key Behaviours as part of Performance Development:  Commitment/Personal Accountability  Professional/Technical Expertise  Teamwork  Customer Focus  Effective Communications & Relationships  Knowledge of and demonstrated commitment to the principles of the Treaty of Waitangi Personal Attributes:  Is a team player, however is able to work independently  Is proactive, energetic and uses initiative  Has strong administrative and organisational skills  Is self-motivated and innovative  Is results orientated  Understands ethics and privacy  Is friendly, helpful and displays a genuine interest in people  Easily establishes a rapport with people of varied ages and from diverse backgrounds and cultures  Contributes effectively to the BOP Clinical School team  Is able to build positive working relationships with DHB staff and external contacts  Practises cultural safety

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