Job Specifications
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Job Overview
The Clinical Studies Officer will work to support the research nurses and other trials staff with responsibility for the routine day-to-day administration of research studies and their associated work and to facilitate the optimum recruitment of patients to clinical trials
The post holder will be responsible for the set up, maintenance, and close down of studies including those adopted to the NIHR Portfolio, in accordance with local, national and international legislation.
The post will entail assessing patients’ suitability, ensuring informed consent is obtained; co-ordinate the logistics for patient visits and undertake patient assessments in accordance with study protocol.
All data to be recorded, including adverse and serious adverse events, in accordance with ICH-GCP including UK statutory Instruments as well as ISO 14155 local national and international legislation.
Facilitate the set-up of studies working with the Research & Innovation department and relevant networks. It will be the post holders responsibility to ensure studies are delivered in line with agreed targets
Main duties of the job
The post holder will be responsible for the set up, maintenance, and close down of studies including those adopted to the NIHR Portfolio, in accordance with local, national and international legislation.
The post will entail assessing patients’ suitability, ensuring informed consent is obtained; co-ordinate the logistics for patient visits and undertake patient assessments in accordance with study protocol.
All data to be recorded, including adverse and serious adverse events, in accordance with ICH-GCP including UK statutory Instruments as well as ISO 14155 local national and international legislation.
Facilitate the set-up of studies working with the Research & Innovation department and relevant networks. It will be the post holders responsibility to ensure studies are delivered in line with agreed targets
Working for our organisation
North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead. We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialities. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.
North Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.
Detailed Job Description And Main Responsibilities
Trial Set-Up
Advise on protocol feasibility, safety, regulatory and operational requirements.
Coordinate feasibility work, site-specific assessments, trial set-up meetings, and required approvals with R&I and NIHR RRDN.
Support contract negotiations, costings, and establish governance-compliant systems.
Manage set-up across the Trust and ensure study records (e.g., EDGE) are accurate.
Trial Delivery
Support Principal Investigators in meeting governance and regulatory obligations.
Maintain essential documentation, complete CRFs/eCRFs accurately, and oversee AE reporting.
Recruit, consent, and monitor participants; ensure protocol adherence and accurate clinical documentation.
Liaise with multidisciplinary teams, sponsors, and NIHR RRDN to address operational issues.
Manage multiple studies, contribute to SOPs and governance activity, and maintain recruitment data on EDGE.
Study Close-Out
Transition participants back to usual care, complete data cleaning, resolve queries, and archive documentation in line with GCP.
Support publication and dissemination act
About the Company
As one of the largest NHS trusts in the country, we serve a local population of around 500,000 people across South Gloucestershire, North Somerset and North Bristol. We are a centre of excellence in a wide range of specialties, including orthopedics, neurosciences, renal, transplant, and neonatal care.
We work hard to maintain an environment of continuous learning and development. We are the largest teaching trust in the South West, working in partnership with the University of the West of England and the University of Bris...
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