Clinical Studies Officer

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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
• Coordinating the logistics for patient visits
• Undertaking 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 holder's 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.
• Assessing patients’ suitability, ensuring informed consent is obtained; coordinating the logistics for patient visits and undertaking patient assessments in accordance with study protocol.
• Recording all data, 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.
• Facilitating the set-up of studies working with the Research & Innovation department and relevant networks. Ensuring 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.

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 activities.
• Project Management
  • Apply project management processes throughout set-up, delivery, and close-out.
  • Contribute to improving study flow, set-up efficiency, and integration of research into clinical care.
• Audit, Monitoring, and Education
  • Audit research projects and follow up required actions.
  • Identify training needs, maintain training records, and undertake mandatory development.
• Additional Duties
  • Provide governance advice, support policy/SOP development, collate research outputs, maintain confidentiality, and assist teams with recruitment as needed.

Person specification
Education/Training/Qualifications
Essential criteria

• Significant research delivery experience in Movement Disorders
• GCP certificate

Work experience
Essential criteria

• Effective personal time and case load management
• Project Management skills
• Recent Clinical Research Experience (band 4 or above)

Knowledge/Skills/Abilities
Essential criteria

• Advanced communication skills, verbal & written, to include report writing and record keeping
• Excellent interpersonal skills with patients and multidisciplinary team
• Evidence of continuing professional development

Personal Qualities/Special Circumstances
Essential criteria

• Able to work within a diverse community of patients and health care professionals
• Ability to be mobile to meet the demands of the post

If you apply for this vacancy and have not received a communication from North Bristol NHS Trust within three weeks of the closing date, please assume that on this occasion your application has been unsuccessful.

Please note that North Bristol NHS Trust does not reimburse travel expenses relating to interview attendance.

North Bristol NHS Trust is committed to safeguarding and promoting the welfare of children and young people and expects all staff and volunteers to share this commitment.

The successful applicant(s) will normally commence at the minimum of the scale unless they have previous NHS service at the same band. Progression through the scale is by annual increments.

At North Bristol Trust (NBT), we know diverse and inclusive environments lead to happier and healthier teams and improved patient care and outcomes. We are committed to equality of opportunity, to being fair and inclusive, and to being a place where we all belong. We therefore particularly encourage applications from candidates who are currently underrepresented in NBT’s workforce at Band 8a and above. These include people from Black, Asian and minority ethnic backgrounds, disabled people and LGBTQIA+ people.

Please note that stringent pre-employment checks are undertaken on all successful applicants prior to commencement in post.