POSITION DESCRIPTION

Position Title: Casual Research Nurse

Position Holder’s Name:

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Position Holder’s Signature:

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Business Manager’s Name:

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Business Manager’s Signature:

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Date:

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Professionally accountable to:

CCRep Research Nurse Manager Principal Investigator

Date Produced/Reviewed:

July 2012

VISION We believe passionately that CCRep has a key role in bringing new healthcare options to the NZ public. We work closely with researchers and investigators producing evidence to support the adoption of new therapies. Our vision “Creating the Future of Healthcare” encapsulates how CCRep sees itself.

VALUES CCRep’s values flow from our vision. CCRep is a leader in the field of clinical research and our people bring the capability, experience and quality required to achieve our goals. Creativity Commitment Research Experience People

– leading and innovating in health research – showing care and respect for research participants – delivering excellence in performance and clinical practice – using expert knowledge for maximum benefit – one team, working together with respect and integrity

PURPOSE OF THE POSITION To provide support and backup for any Research Nurse / Coordinator who is the sole practitioner within a specific therapeutic area. To provide support and assistance to Research Nurses / Coordinators during peaks of workload, and to cover for leave. Provide appropriate clinical nursing insight and management to participants enrolled in clinical research trials and support for their family/whanau across the continuum of care in line with vision and values of CCRep.

Organisational Structure July 2012

Management Group

Board of Trustees

General Manager

Tissue Bank Clinical Director

RSO/Administrator

Biostatistician

Business Managers (x3)

Clinical Research Staff Recruitment Specialist Regulatory Specialist Research Development Coordinator

Clinical Director

Finance Manager

Research Nurse Manager

Tissue Bank Curator

D’base Administrator Asst. Accountant

HR/Admin Assistant Research Assistant

Collection Technician

FUNCTIONAL RELATIONSHIPS Internal:

Business Manager, CCRep Research Nurse Manager, CCRep General Manager, CCRep Clinical Director, CCRep Other Research Nurses/Coordinators/Assistant Research Support Officer/Admin.

External:

Principal Investigators/researchers Trial participants Research Sponsors/Monitors CMDHB service departments and employees Community Health Providers.

NATURE AND SCOPE OF RESPONSIBILITES KEY ACCOUNTABILITY UTILISE • CLINICAL RESEARCH • NURSING SKILLS • AND EVIDENCE BASED PRACTICE • TO PROACTIVELY MANAGE • PARTICIPANTS WITHIN TRIAL • PROTOCOLS • • • • • • • • • •

To assist Research Nurses/Coordinators in the management of participants and trials when additional assistance is required. Complies with CCRep Standing Orders To work collaboratively with the research team to achieve appropriate clinical outcomes and effective trial management. Utilises nursing and research knowledge to provide clinical expertise and case management for participants within the research protocol guidelines. Promotes professional standards of nursing practice and ensures practice is validated with best practice and research activities. Demonstrates an understanding of experimental therapy and the rationale behind the research trial. Identifies potential participants, reviews their clinical condition and medical history and assesses suitability for inclusion in trial, and recruits as per trial protocol. Ensures informed consent is obtained and information sheet is read and fully understood. Co-ordinates participants clinic appointments within trial specific timeframes and participant needs. Assesses participants enrolled in clinical trials and develops implements and maintains plans of care. Liaises with medical staff and primary care team as appropriate on medical conditions ensuring investigations and changes in care are implemented. Co-ordinates, undertakes and reports all necessary investigations tests and administration of questionnaires required for the trial within specified timeframes. Educates participants and/or family about their medical condition as necessary. Provides trial medication to participants, ensuring participants safety secure storage of medication, and maintenance of medication logs. Draws blood, centrifuge and freeze as instructed and prepare samples for shipment ensuring that documentation at all stages of the process is completed accurately Demonstrates excellent written and verbal communication skills with

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participants, family/whanau, CCRep staff and management and CMDHB staff and Trial Sponsors Ensures all documentation is appropriate and accurately completed from development of source documentation, maintenance of trial master file, creation of Standard Operating Procedures, completion of CRFs/eCRFs documentation of Monitors visits to close-out and archiving procedures. Ensures all trial activity is recorded in Clinical Conductor in accordance with CCRep guidelines and expectations. Ensures clinical trials are conducted within ICH/GCP guidelines. Records all adverse events and reports serious adverse events within required timeframes.

COMPLIANCE WITH REGULATORY REQUIREMENTS RELATED TO CLINICAL TRIALS

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FINANICAL MANAGEMENT RELATED TO CLINICAL TRIALS ENSURE PRACTICE IS CULTURALLY SENSITIVE

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Aware of need for tight budget control, and audit trail. Clinical Conductor to be integral in daily practice.

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Understands the significance of the Treaty of Waitangi and displays cultural sensitivity. Understands the multi-cultural diversity of participants within the South Auckland area and applies this knowledge when recruiting and managing participants in research trials. Acts as a patient advocate at all times. Recognises and respects individual differences. Actively participates in the CCRep staff meetings, and any initiatives and changes implemented. Identifies the need for trial specific SOPs /Guidelines and disseminates this information/documentation to other members of the team. Actively shares knowledge/information, and provides back-up support for clinical trials and colleagues. Provides supervision for non-nursing personnel in the management of trials, specifically medication administration and clinical assessments. Undertakes other related tasks as requested by their Manager. Aware of employee responsibilities under the Health and Safety in Employment Act 1992 and its amendments. Identifies and reports hazards, and contributes to eliminating, minimising or managing these. Maintains up to date knowledge of Infection Control practices and implements this knowledge into clinical practice. Understands the quality process and is actively involved in implementing improvements. Ensures quality assurance of clinical trial data, and participates in monitoring and audit processes as required.

FUNCTION AS AN EFFECTIVE MEMBER OF CCREP TEAM

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COMPLY WITH BEST PRACTICE GUIDELINES ON HEALTH & SAFETY, INFECTION CONTROL AND QUALITY ISSUES

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PERSONAL PROFESSIONAL DEVELOPMENT

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UTILISE INFORMATION TECHNOLOGY

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Attends educational opportunities, conferences and meetings relevant to role and scope of practice. Maintains up to date knowledge of the changing process in research, clinical management within medical specialities and resources available. Maintains and develops own clinical competence, complying with the requirements of the Health Practitioners Competency Assurance Act (2004). Maintains current in ICH/GCP, Dangerous Goods, Basic Life Support, Patient Safety training. Establishes and maintains effective local, regional, national and international networks within the clinical research field. Maintains and develops data analysis skills. Ensures training and education are up to date in regard to use and understanding of Clinical Conductor. Conversant with applications available and how to access and use clinical information systems including Clinical Conductor. Knowledge of internet-based CRF submission and data recording processes.

PERSONAL QUALITIES, QUALIFICATIONS AND EXPERIENCE EDUCATION EXPERIENCE/ KNOWLEDGE

ESSENTIAL • RGON or R.COMP NURSE • Minimum of 3 years post registration experience. • Knowledge & experience in clinical research trials • Recent practical clinical experience • Advanced patient assessment skills. • Knowledge of legal and ethical responsibilities. • Portfolio to meet Nursing Council Standards. • Competent in the use of information technology.

PREFERRED • Relevant Post Graduate qualification (can be in process of attainment) • Preferably 5 years post registration experience. • Familiar with internet based CRF submission. • Knowledge of legal and ethical responsibilities relating to clinical research. • Ability to critique and use research findings.

PERSONAL QUALITIES

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Authorised Authorised CCRep Representative

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Excellent written and verbal communication skills. Ability to work autonomously to achieve targets and to work co-operatively in a multidisciplinary team. Excellent organisational skills Excellent interpersonal skills.

Accepted Casual Research Nurse

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