Clinical:
Develop and expand a clinical research delivery team with the skills and knowledge to ensure safe and effective coordination, monitoring and care of patients taking part in research in the CRF. Ensure all clinical procedures are undertaken using Trust policies, study protocols and evidence-based practice, and that the team continually update their practice to adhere to good practice. Develop and maintain skills including research nursing skills, cannulation, phlebotomy, ECG recording, and any other study investigations and interventions as necessary. Provide hands-on patient care and research delivery activity such as: Giving information to patients about research studies, undertaking informed consent, randomisation, treatment allocation and administration, follow-up visits, data entry, as well as taking blood samples, ECGs and other standard core investigations.
Provide advice, support and direct care to patients and their families involved in (and at all stages of) clinical research studies, acting at all times in a way that maintains patients' and carers' dignity. Collaborate with and share information across clinical teams as appropriate including other Research Delivery Teams across the Trust. Ensure detailed and accurate participant records are maintained within the team, using consistent audit and reporting processes.
Ensure appropriate and timely reporting of adverse events and serious adverse events in line with local Trust policies, standard operating procedures and research specific protocols. Act appropriately to record, report and ensure timely follow-up care is provided for trial participants, including communication with the PI and relevant local personnel and regulatory authorities.
Research, Management and Leadership:
Provide line-management for the CRF Research Delivery Team, ensuring that regular supervision, Personal Development Reviews (PDR) and training is implemented and maintained, and that the performance and professional conduct of the team is monitored and managed. Facilitate effective team communication and collaboration across the team, through regular team meetings to ensure that appropriate information is disseminated.
Engage actively with research activities promoted by the CRF and/or CTU. Participate in CTU Project Review Panel and other departmental meetings as required. Actively participate in UKCRF activities and management group. Work collaboratively with the Senior Management Team (SMT), PIs and their teams, as well as other individuals/organisations, to manage and coordinate the processes involved in the feasibility assessment, set-up and successful delivery of clinical research projects in the CRF. Ensure appropriate review of each trial protocol and identify resource implications for the CRF, including collaboration with R&I and support departments such as pharmacy and pathology.
Work with CRF Manager and finance team to manage requests for ballpark costing for grant applications as well as full costings for new studies. Be accountable, as delegated by the PI, for the documentation of trial data according to relevant regulatory guidelines (ICH GCP) and ensuring ethical approval, Trust approval and indemnity are in place prior to studies commencing on the CRF.
Utilise knowledge in clinical trials methodology, pharmacology and critical appraisal, to ensure that the research portfolio within the CRF is conducted to the highest standard according to ICH GCP principles. Act as an expert source of guidance to nurses and multidisciplinary colleagues regarding clinical research. Contribute to the development and implementation of new policies and procedures for the CRF, for example Standard Operating Procedure (SOP) and Clinical Guideline review and development.
Provide effective budget management and oversight of funding and resource allocation. Utilise data systems such as EDGE, work with the R&I/CTU Data Officer and the CRF delivery team to manage the collection and presentation of data regarding performance targets, recruitment and other metrics as required, including the National Institute for Health Research (NIHR) CRF Annual Report. Represent the CRF at local and national meetings as required.
Work alongside R&I Patient and Public Involvement/Engagement (PPI/E) staff to actively encourage and participate in PPI activities, so that the views of patients are integrated into research activities. Engage and respond to patient feedback in relation to their research experience, and as far as possible, work with patients to develop all aspects of research development, engagement and delivery. Evaluate the changing needs of the research portfolio within the CRF and work with the Senior Management Team to adapt the focus of delivery in line with changing research priorities and the overarching CRF strategy, supporting a culture of safety that is open and honest.
Education and Professional Development:
Work with the SMT to develop and maintain a structured training and professional development program for research delivery staff in the CRF. Ensure new starters are effectively orientated to the CRF Team and receive ongoing support and education relevant to their roles. Facilitate team engagement with public events and activities pertaining to research, such as Open Days and presentations. Contribute to the delivery of educational programs for staff and students relating to research and clinical care.
Develop personal and professional knowledge through study, critical self-appraisal, clinical supervision, PDR and networking with other health professionals locally and nationally. Identify and undertake appropriate learning opportunities to promote self and shared learning at an individual and team level. This is a fantastic opportunity for the right person to make a significant impact in the world of clinical research, with ample opportunities for personal and professional development. Join us and help shape the future of research.
Your expertise and leadership will leave a lasting mark on our commitment to advancing medical science and improving patient outcomes.
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