Date: September 2015 Job Title : Clinical Research Nurse Department : Haematology Research Unit General Medicine & Older People Location : North Shore Hospital Reporting To : Operationally to: Operations Manager Haematology Professionally to: Manager Awhina Research, Innovation & Knowledge/ Nurse Consultant (Research) Direct Reports : Nil Functional relationships Internal Awhina Research & Knowledge Director of Nursing and Midwifery Clinical Research Nurses Researchers Maori Research Advisor Waitemata DHB Clinical and Allied Health Waitemata DHB legal Three Harbours Health Foundation Interdisciplinary support personnel External Patients & their significant others General Practitioners Pharmaceutical/Device Companies Contract Research Organizations Academic Research partners Health & Disability Ethics Committees NZ DHB Researchers District Health Nurses Purpose : The specialty nurse role of clinical research nurse is multi-dimensional. It involves nursing care provided to research participants in the health care setting, as well as activities to project manage and support the conduct of ethical research and clinical audit /evaluation projects. Clinical Provide excellent evidence based care and nursing skill for clinical trial research Demonstrates professional accountability and leadership Proficient practice. Skilled nursing care for a wide range of clinical needs. Exhibits advanced clinical assessment skills and care planning. Establishes and maintains positive working relationship with key personnel throughout the hospital Maintains clinical skills to be able to assist with the management of emergencies and complex situations Participates as a member of the clinical research nurses community of practice and implements clinical practice initiatives, systems and processes to ensure consistency of best practice. Recognises the importance of referral to, and accepts advice of other clinical specialists and educators to ensure best practice when caring for patients with diverse and complex needs. Ensures that appropriate equipment is available and maintained Waitemata District Health Board -JOB DESCRIPTION - Clinical Research Nurse July 2013 Page 1
to allow for appropriate monitoring and care delivery. Participant/client protection Recognises the importance of acknowledging the context in which clinical research is undertaken Ensures the initial and ongoing informed consent process Supports participant/client in defining his/her reasons and goals for participating in clinical research Acts as the primary research team contact for clinical trial participants and their families. Advocates for participant/client and accesses resources (where appropriate and agreed) Collaborates with the interdisciplinary team to ensure best practice and ethical compliance Coordinates research activities to minimise participant/client risk Maintains participant/client privacy and confidentiality of data Research management Works within the clinical research team with supervision where required from principal investigator. Safe and effective conduct of clinical trials to standards set out within Waitemata DHB policy and to ICH- GCP guidelines. Flexible working patterns to meet the protocol timelines of a clinical trial Good Clinical Research Practice and IATA Dangerous Goods Transportation (Infectious Substances) training up to date Provides project management for clinical research studies Provide documentation and reports in compliance with ethical and/or regulatory requirements Prepares project documentation for ethical, regulatory and locality management review Develops clinical research budget draft & supports the investigator in associated budget negotiation with sponsor/institution Manages multiple projects simultaneously. Works autonomously and also contributes collaboratively, cooperatively and effectively in the interdisciplinary team Works to agreed clinical trial protocols approved by the appropriate research ethics committees. Completes documentation of clinical trial data in case record forms (CRFs), clinical notes clearly in accordance with ICH GCP guidelines and the clinical trial protocol requirements Quality assurance of data integrity ensures it is attributable, legible, contemporaneous, original & accurate Ensures systems, processes and resources to support research team and other staff meet the needs of the participant/client in an efficient and effective manner Provides ongoing documentation and data management for clinical trials research, observational research and audit based activities as directed Understands the requirements for the conduct clinical trials. Adheres to Waitemata DHB policies and procedures, practices within the professional codes of conduct for health care professionals and works within own scope of practice. Liaises with investigators, study sponsors, study monitors, and regulatory bodies as required and /or directed. There is demonstrated commitment to good customer service standards. Good relationships are evident with other departments and support personnel. Waitemata District Health Board -JOB DESCRIPTION - Clinical Research Nurse July 2013 Page 2
Care Coordination & Continuity Contribution to Knowledge & Science Personal & Professional Development, Accountability & Leadership Responsible for developing and sustaining own knowledge, clinical skills and professional awareness in accordance with professional development requirements To recognise Individual Responsibility for Workplace Health and Safety under the Health and Safety in Employment Act 1992 Responds to research participant/client inquiries and concerns Coordinates participant/client research visit schedule Refers participant/client appropriately to interdisciplinary services outside immediate clinical research team Ensures active transfer of care at conclusion of participant/client research study involvement Demonstrates excellent communication and conflict resolution skills. Disseminate clinical expertise and best practices related to clinical research through presentations, publications with nursing and interdisciplinary colleagues Serves as expert in specialty area and contributes to the development and training of other staff and researchers Participates (where appropriate) in the analysis of research data Collaborates with the interdisciplinary team to develop innovations in care delivery that have the potential to improve patient outcomes Identifies questions appropriate for clinical nursing research as a result of clinical research Early adopter/promoter of new evidence based practice techniques that result from clinical research outcome Mentors junior staff and students new to clinical research team Is highly clinically proficient and respected for ability to support the team with care delivery in this specialty Is up to date with international best practice in the specialty and attends conferences, on-line learning and reads journals to maintain currency Seeks regular professional supervision to discuss how to address areas of difficulty and review quality of practice. Pursues a program of self-development to broaden critical thinking and leadership skills. Engages in activities of continuous learning, including in-service, self-learning, study days, post graduate study Participates in nursing and organisational activities and committees Maintains professional development. Professional development is actively pursued through active participation in in-service or post graduate education, keeping up to date with relevant literature or using other resources to maintain knowledge Presents own portfolio for assessment that meets the Nursing Council of New Zealand competencies expected of a senior nurse Company health and safety policies are read and understood and relevant procedures applied to their own work activities Workplace hazards are identified and reported, including self management of hazards where appropriate Can identify health and safety representative for area Waitemata District Health Board -JOB DESCRIPTION - Clinical Research Nurse July 2013 Page 3
VERIFICATION: Employee: Manager: Date: Note: This job description forms part of an individual s contract of employment with WDHB and must be attached to that contract. Behavioural Competencies Adheres to Waitemata District Health Boards 4 Organisational Values of: Every single person matters, whether a patient / client, family member or a staff member We see our work in health as a vocation and more than a job, We are aware of the suffering of these entrusted to our care. We are driven by a desire to relieve that suffering. This philosophy drives our caring approach and means we will strive to do everything we can to relieve suffering and promote wellness. We need to be connected with our community. We need to be connected within our organisation across disciplines and teams. This is to ensure care is seamless and integrated to achieve the best possible health outcomes for our patients/clients and their families. We seek continuous improvement in everything we do. We will become the national leader in health care delivery. Behavioural Competencies Behaviour Demonstrated Communicates and Works Cooperatively Actively looks for ways to collaborate with and assist others to improve the experience of the healthcare workforce, patients & their families and the community & Iwi. Is Committed to Learning Proactively follows up development needs and learning opportunities for oneself and direct reports. Is Transparent Communicates openly and engages widely across the organisation. Enacts agreed decisions with integrity. Is Customer Focused Responds to peoples needs appropriately and with effective results Identifies opportunities for innovation and improvement Works in Partnership to Works in a way that: Reduce Inequality in Outcomes Demonstrates awareness of partnership obligations under the Treaty of Waitangi. Shows sensitivity to cultural complexity in the workforce and patient population. Ensures service provision that does not vary because of peoples personal characteristics. Improves health Work practices show a concern for the promotion of health and well-being for self and others. Prevents Harm Follows policies and guidelines designed to prevent harm. Acts to ensure the safety of themselves and others. Waitemata District Health Board -JOB DESCRIPTION - Clinical Research Nurse July 2013 Page 4
POSITION TITLE: Clinical Research Nurse PERSON SPECIFICATION Expectations Qualifications Registered Nurse Scope of Practice (RGON, RCpN, RPN, BHSc) Current Annual Practicing Certificate Experience Registered Nurse Level III or IV with at least 5 years post graduate experience. Wide experience in most aspects of patient care. Acute setting experience essential Specialty clinical research nurse experience Demonstrated technical literacy in Microsoft Office suite Demonstrated understanding in research budget presentation Experience with IVRS and electronic CRF reporting methods Current and up to date portfolio demonstrating competency in practice at Level 3 or 4. Ability to effectively share clinical knowledge with others and seek guidance and advice from medical associates Phlebotomy skill and IV cannulation skills Current CPR Level 3 and IV certification/medication assessment skills Personal Positive manner, flexible, able to influence without conflict, motivating attributes Excellent communicator, highly articulate, an active listener, has a way of valuing everyone s opinions Strong leader and team member Strong commitment to quality improvement Excellent customer service focus and skills Calm, even, consistent and mature personality Professional and sensitive approach when dealing with the needs of individuals and groups balanced with the needs of the service Self-directed, proactive, uses initiative, confident skill in negotiation and consultation Manages personal stress effectively. Maintains high level of activity and productivity Skills / Knowledge / Behaviour Excellent planning & time management skills Demonstrated ability to balance competing priorities, complex situations and tight deadlines Current knowledge of guidelines, policies and NZ legislation related to clinical trials for example GCRP, ICH-GCP, FDA guidelines, HDEC guidelines & similar Ability to establish and maintain professional relationships and networks Ability to work collaboratively and independently High level of personal motivation, integrity, and initiative Able to work flexible hours Self-directed/use of initiative, confident skill in negotiation and consultation Upholds confidentiality with a reputation for high integrity and discretion Waitemata District Health Board -JOB DESCRIPTION - Clinical Research Nurse July 2013 Page 5