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Clinical Research Associate
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Clinical Research Associate
An exciting opportunity is available for an experienced Clinical Research Associate (CRA) to support the successful delivery of clinical trials across South West England. This role is responsible for monitoring clinical research sites, ensuring compliance with regulatory standards, and maintaining high-quality study execution from start-up through close-out.
Key Responsibilities
- Conduct site selection, initiation, routine monitoring, and close-out visits in accordance with study protocols, Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
- Build and maintain strong relationships with investigative sites to ensure successful study delivery.
- Support and monitor patient recruitment and enrolment activities, helping sites achieve study targets.
- Deliver protocol and study-specific training to site staff and provide ongoing guidance throughout the study lifecycle.
- Assess site performance, protocol compliance, and data quality, identifying and escalating issues where appropriate.
- Track study progress, including regulatory approvals, recruitment, case report form (CRF) completion, and query resolution.
- Ensure Trial Master File (TMF) and Investigator Site File (ISF) documentation is accurate, complete, and inspection ready.
- Prepare monitoring reports, follow-up letters, and all required study documentation within agreed timelines.
- Collaborate with cross-functional study teams to support project milestones and successful trial execution.
- Contribute to study start-up activities where required.
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Requirements
- Minimum of 2 years' independent on-site monitoring experience within interventional clinical trials.
- Experience across the full clinical trial lifecycle, including study start-up, enrolment, maintenance, and close-out.
- Degree in Life Sciences, Healthcare, Nursing, Pharmacy, or a related scientific discipline, or equivalent industry experience.
- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable clinical research regulations.
- Excellent organizational, communication, and stakeholder management skills.
- Strong attention to detail with the ability to manage multiple studies and priorities.
- Confident using digital technologies and AI-enabled tools in a professional environment.
- Full right to work in the UK.
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This is an excellent opportunity for an experienced Clinical Research Associate looking to join a collaborative clinical research environment while supporting the successful delivery of innovative clinical trials that improve patient outcomes.
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