CRA/Senior CRA
Listed on 2026-02-19
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Science
Clinical Research, Research Scientist
Senior Clinical Research Associate (CRA) - Fixed-Term Contract (15-16 months)
Location: UK - Multi-site (England)
Contract: Fixed-term (15-16 months)
The OpportunityAn exciting opportunity has arisen for an experienced Senior Clinical Research Associate to join a growing clinical operations team within a UK-based, clinical-stage biotechnology organisation.
This role is suited to a senior CRA with strong hands‑on monitoring experience who is confident operating at a lead level, maintaining inspection readiness, and overseeing complex site activity. You will play a key role in ensuring high‑quality trial delivery, proactive risk management, and regulatory compliance across a multi‑site UK study.
The position requires sustained weekly travel and biweekly on‑site monitoring visits across assigned trial sites.
Key Responsibilities- Conduct advanced on‑site monitoring visits, including full 100% source data verification (SDV).
- Provide oversight of monitoring quality across all sites and ensure inspection readiness at all times.
- Identify and mitigate emerging risks related to data quality, site performance, patient safety, and compliance.
- Mentor and support CRA I/II colleagues, improving monitoring efficiency and consistency.
- Build strong relationships with site staff and act as the primary escalation point for operational or quality issues.
- Lead the resolution of protocol deviations, data queries, and complex operational challenges.
- Contribute to oversight reporting, risk assessments, and study‑level decision making.
- Ensure strict adherence to ICH‑GCP, UK regulatory requirements, and internal SOPs.
- Significant experience working as a CRA, including responsibility for complex monitoring activities.
- Strong working knowledge of ICH‑GCP, MHRA expectations, and UK clinical trial regulations.
- Proven ability to independently manage multiple sites with high monitoring intensity.
- Experience mentoring, supporting, or overseeing junior CRAs or site teams.
- Excellent problem‑solving skills with the ability to anticipate and proactively mitigate risk.
- High attention to detail, strong organisational capability, and excellent communication skills.
- Ability to manage sustained weekly travel across UK trial sites.
- Full right to work in the UK (visa sponsorship not available).
- Experience in gastroenterology or IBS / CIC clinical studies.
- Exposure to PRO‑driven endpoints and symptom‑based GI trials.
- Full UK driving licence (advantageous but not essential).
To find out more about this opportunity, please contact Lynsey today on
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