Senior Research Nurse

Unit Management

• Manage a designated number of research studies.
• Maintain a safe environment for patients, staff and visitors, ensuring compliance with NGH current policies and procedures, and any statutory requirements, including all Health and Safety and Clinical Governance arrangements.
• Use judgement in relation to competing demands for funding, staff and team resources.
• Contribute to the control of the research unit budget ensuring adequate measures exist for delivery of the research studies.
• Respond to change in line with the needs of service provision.
• Responsible for the development and updating of team policies and procedures.
• Ensure that all record keeping within the department is appropriate, timely and clearly understood for the purpose of patient care, safety and data integrity.

Education

• Identify own learning needs and proactively seek educational opportunities to fulfil them.
• Develop skills in accordance with the NIHR CRN Competency Framework for research delivery staff appropriate to the Band 6 role.

Strategic Role

• Be a champion of clinical research.
• Support and influence the embedding of clinical research within the Trust.
• Foster good relationships with key division research leads, support departments, Institutes and partners to promote the efficient running of clinical trials and develop the Trust research portfolio.
• Contribute to the development and updating of research policies and procedures within NGH.
• Take an active role in the activities of professional forums and networks.
• Disseminate the results of research into clinical nursing practice.

Staff Management

• Line manage research nurses and A&C staff within the team as agreed.
• Assist with the recruitment, selection, induction and orientation for new research nursing, allied health professional and administrative staff.
• Facilitate effective and cohesive team working, developing relevant clinical skills, delivering studies to time and target.
• Provide day-to-day management of the research team in the absence of the Clinical Research Managers, ensuring compliance with trust policies and guidelines.
• Act as a role model in establishing good practice and standards of care and management.
• Responsible for effective communication within the nursing teams ensuring all members are well briefed on key departmental and corporate issues.
• Promote a patient-focused approach centred on care and compassion, ensuring courtesy and respect at all times.
• Ensure that standard operating procedures are followed by all members of the research team.
• Instigate and oversee Quality Improvement projects in Research & Innovation.

Study Set Up

• Ensure all elements of set up are completed in accordance with UK and EU legal requirements, Trust policies and ICH-GCP or ISO 14155.
• Signpost to advice and guidance on matters relating to research ethics and governance and in preparing submissions for regulatory and trust approval.
• Have a detailed knowledge and understanding of research design and methodology.
• Contribute to the assessment of study protocols and advise on safety, regulatory and logistical issues.
• Provide oversight for the set-up of a designated number of research studies within the team, acting as point of contact for R&I in the feasibility process.
• Project manage study set up with colleagues from around the Trust and within the University of Northampton.

Study Conduct

• Support local Principal Investigators in meeting their responsibilities outlined in regulatory and legal frameworks.
• Support colleagues and researchers through the research study process, including the delivery of clinical aspects associated with the research study.
• Ensure that processes and procedures for ensuring participant confidentiality are developed and adhered to in compliance with the Data Protection Act and Caldicott regulations.
• Identify and screen appropriate study participants in accordance with the protocol.
• Receive informed consent for designated research studies as agreed within the protocol.
• Provide knowledge and demonstrate accurate attention to detail in documentation tasks, including Investigator Site File maintenance, CRF completion, and documenting source data.
• Contribute to the auditing and monitoring of research studies; respond to recommendations ensuring outcomes are shared within the division and wider UHN research community.
• Act as a resource to PIs in ensuring all Adverse Events and Serious Adverse Events are reported in line with ICH-GCP, ISO 14155 and UHN Adverse Events Reporting policy.
• Liaise with the R&I department in identifying barriers to recruitment and the running of the study; support the study team in developing strategies to mitigate them.
• Support the study team in ensuring all reporting to regulatory bodies, R&I and Research Networks is completed in a timely manner.
• Ensure that all equipment used is appropriately checked and calibrated with supporting documentation retained.
• Liaise with Sponsors to ensure all arrangements for research governance for each study are in place.

Study End

• Ensure all data clarification issues are resolved quickly.
• Manage the archiving of study-related documentation in line with the Trial Agreement and ICH-GCP / Medicines for Human Use (Clinical Trials) Regulations / ISO 14155.
• Ensure a smooth transition from the research pathway back to the conventional treatment pathway.