CRF Senior Clinical Research Nurse
3 weeks ago
Job summary
We are looking for an exceptional senior research nurse to join the clinical research facility (CRF) research team. This post will provide clinical leadership for our expanding research portfolio, manage junior research delivery staff and support the team to deliver high-quality research.
You will be responsible for the management of your team's research portfolio, reviewing protocols, amendments and identifying resource implications. You will have line management responsibilities and will actively be involved with staff recruitment, training, supporting and mentoring of all team members.
Applicants must be a registered adult nurse with evidence of continuing professional development. You should have good experience in clinical research within the NHS, a strong clinical background and desire and willingness to learn and develop others. Essential skills are excellent communication and interpersonal skills, the ability to multitask and meet tight deadlines, the ability and initiative to work independently and manage a patient caseload across a variety of research studies.
The post holder is expected to work on shift patterns necessary to ensure patient safety and timely delivery of clinical trials. Work patterns will include day shifts, regular late and night duties and weekends as required.
Main duties of the job
Responsibilities will include the co-ordination of a portfolio of early phase translational clinical research, collaborating with key personnel throughout the two adult Clinical Research Facilities (CRF), to ensure continued care and support for patients and healthy volunteers involved in these clinical trials and studies. The post holder will take responsibility for supervising the safe administration of experimental therapies, and for monitoring the effects of drugs and other treatment modalities used in these trials. They may also be involved in gaining ethical approval, collecting data, interviewing and data entry.
The post holder will be expected to advocate for patients and empower them to make informed choices concerning their involvement in the clinical trials by providing advice and information.
The post holder will be involved in improvement projects to further develop the operational aspect of the CRFs. This includes attending feasibility and initiation meetings, monitoring CRF supplies and equipment, facilitating orientation and support of external staff to the CRF. Aspects of the role will include clinical tasks such as phlebotomy, analysis of blood specimens, drug administration and clinical observation.
The post holder will work with a high level of autonomy, taking delegated responsibility from Clinicians for clinical decision making, and will work closely with the Investigator and multidisciplinary staff.
About us
The postholder will interact with a wide range of internal and external stakeholders involved in the delivery of the Trial including clinicians, research and health care managers, research delivery staff and research participants. Staff within the Medical School and other relevant hospitals and Trusts, non-commercial bodies and Pharmaceutical companies and/or sponsors. The postholder will lead a research nursing team dedicated to the delivery of the study.
Job description
Job responsibilities
The post holder will:
Lead on participant communications and well-being issues,providing specialist advice relevant to clinical research nursing Be responsible for leading aresearch nurse team to support screening of eligible research participants including providing information and support to participants, clinical follow-up, data collection and safety reporting according to requirements Work with the CRF Matron toestablish and maintain key strategic relationships with networks of clinicians, researchers and health service managers for effective roll-out of thetrial Work alongside a team oftrial coordinators, data managers and database developers to ensurecompliance withGCP,dataprotection and research governance frameworks, regulations and sponsorrequirements Supportthedevelopment of trainingmaterialsfor clinical research staff at study sites including study specific and informed consent training and elements of GCP Monitor participants experience and identify importantparticipantswell-beingissues Be a central point of contact for site staff for trial-specific procedures including support to participants, eligibility assessment, informed consent, and sample management. Person Specification
Knowledge/Qualifications
Essential
NMC Level One Registration - RN Adult Your professional knowledge acquired at degree level will be supplemented by specialist training, experience and/or short courses ICH GCP certificated Post-registration teaching qualification ( 998 or mentorship course)
Desirable
Relevant masters level qualification or higher
Skills
Essential
You have evidence of excellent communication and interpersonal skills Ability to work autonomously and as a member of a small team, as well as part of the wider multidisciplinary team in relation to clinical trials You will have the dexterity and coordination needed for undertaking venepuncture, intramuscular, skin punch biopsies and accuracy required for intravenous injections, syringe pumps and infusions. You will possess basic laboratory skills such as centrifugation and sample separation Ability to set direction, manage and lead a team of research professionals You will be able to plan and organise complex activities and programmes, requiring formulation and adjustment as necessitated Site File and Database management You will recruit to, support and develop a specialist nursing service provision. You will be able to teach/deliver core training of individual clinical trial/study protocols to junior members of staff.
Desirable
Systemic Anti-cancer Therapies (SACT)/ Chemotherapy accreditation Immediate Life Support (ILS) accreditation
Experience
Essential
You will have substantial experience in clinical trials, teaching and mentoring as demonstrated by your individual portfolio You will have in depth knowledge of clinical trials and the drug development process. You will be able to clearly demonstrate your knowledge and understanding of current UK clinical trial regulations, good clinical practice and the Declaration of Helsinki 1996 You will have the experience to deliver specialised programmes of care, and provide highly specialised advice for patients and healthy volunteers who are participating in clinical trials You will have experience of being able to facilitate and undertake R&D activities as major job component and undertake research, lead clinical audit in your area Knowledge and experience of handling complex relationships
Desirable
Experience with First-in-Human/ early phase study delivery-
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