- Company Name
- North Bristol NHS Trust
- Job Title
- Clinical Studies Officer
- Job Description
-
**Job Title**
Clinical Studies Officer
**Role Summary**
Provide day‑to‑day administration and support for clinical trials, ensuring compliance with ICH‑GCP, ISO 14155, and UK statutory regulations. Manage study set‑up, conduct, and close‑out activities, coordinate participant recruitment, data capture, adverse event reporting, and liaise with investigators, sponsors, and regulatory bodies.
**Expectations**
- Manage multi‑study portfolio within an NIHR‑aligned research environment.
- Ensure all study documentation, approvals, and governance structures meet national and international standards.
- Deliver recruitment and protocol adherence targets while maintaining high data integrity.
**Key Responsibilities**
- Negotiate and secure study contracts, budgets, and governance approvals.
- Coordinate feasibility assessments, site‑setup meetings, and regulatory submissions.
- Maintain accurate study records (e.g., EDGE, CRFs/eCRFs).
- Recruit, consent, and monitor participants; oversee site visits and assessments.
- Record and report all adverse and serious adverse events per ICH‑GCP.
- Liaise with multidisciplinary teams, sponsors, and NIHR RRDN to resolve operational issues.
- Manage study close‑out: data cleaning, query resolution, archiving, and transition to usual care.
- Support dissemination activities, including publication preparation.
**Required Skills**
- In‑depth knowledge of ICH‑GCP, ISO 14155, UK statutory instruments, and NIHR processes.
- Proficiency in clinical trial management systems (e.g., EDGE, eCRF platforms).
- Strong data entry and data‑management capabilities.
- Ability to manage multiple concurrent studies with rigorous attention to detail.
- Excellent communication and stakeholder‑management skills.
- Experience with protocol feasibility, site‑specific assessments, and regulatory approvals.
**Required Education & Certifications**
- Bachelor’s degree in Nursing, Health Sciences, or related discipline (or equivalent clinical research experience).
- Clinical Research Professional (CRP) or equivalent certification preferred.
- Demonstrated experience in clinical trial administration or research nursing roles.