Clinical Research Associate- South West

Job Title

Clinical Research Associate (CRA)

Location

South West Region, UK

Job Description

Make an impact on global health by driving high‑quality clinical research. In this role, you’ll be the primary site contact and operational lead across all phases of clinical trials—ensuring excellence in performance, compliance, and patient safety. Under the guidance of the CRA Manager, you’ll own your sites end‑to‑end, build strong relationships, and help expand our clinical footprint while upholding ICH/GCP and local regulatory standards, our organization’s policies and procedures, quality standards, and adverse event reporting requirements.

What You’ll Do

• Be the primary site contact and site manager throughout the study lifecycle, taking overall accountability for assigned sites.
• Build, nurture, and maintain strong site relationships to ensure stable performance from start‑up through close‑out.
• Perform remote and on‑site monitoring in accordance with ICH‑GCP, local regulations, protocol, monitoring plans, and our organization’s SOPs.
• Ensure high‑quality data is complete, accurate, unbiased—and always with participant rights, safety, and well‑being protected.
• Conduct all site visit types (validation, initiation, monitoring, close‑out), with timely, clear, and comprehensive reporting.
• Drive site readiness, coordinate cross‑functional activities and contribute to site selection and validation.
• Oversee regulatory documentation across start‑up, maintenance, and close‑out; ensure accuracy and timeliness.
• Identify, assess, and resolve site performance, quality, and compliance issues; elevate per the CRA Escalation Pathway when needed in collaboration with the CRA Manager, CRM, TA Head, and CRD.
• Partner across functions (country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ) and with external stakeholders (vendors, IRBs/IECs, Regulatory Authorities).
• Maintain accurate, on‑time documentation in CTMS, eTMF, and related systems.
• Share expertise as a process SME; mentor/buddy peers and contribute to team best practices.
• Support or lead audit/inspection activities; conduct co‑monitoring as appropriate.
• Expand our research network by identifying and developing new potential sites per country strategy, strengthening local research capabilities.

What You’ll Bring

• Demonstrated experience in clinical monitoring/site management within biopharma, CRO, or academic research.
• Strong working knowledge of ICH‑GCP, local regulations, and clinical trial operations.
• Proven ability to manage multiple sites, priorities, and stakeholders with a solutions‑focused mindset.
• Exceptional communication and relationship‑building skills with investigators and site staff.
• High attention to detail, documentation excellence, and proficiency with CTMS, eTMF, and digital monitoring tools.
• Proactive problem‑solving with sound judgment and timely escalation when needed.
• Bachelor’s degree in life sciences or related field (advanced degree a plus).

Why Join Us

• Meaningful impact contributing directly to advancing clinical science and patient outcomes.
• Growth and mentorship acting as a subject matter expert, mentor peers, and shape best practices.
• Collaborative culture working cross‑functionally with supportive, high‑performing teams.
• Future‑facing operations leveraging modern systems and monitoring approaches to deliver operational excellence.

Closing Date for Applications

23/01/2026

Required Skills

Accountability, Adaptability, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP).