Senior Clinical Research Associate (CRA) - Fixed-Term Contract (15-16 months)
Location: UK - Multi-site (England)
Contract: Fixed-term (15-16 months)
The Opportunity
An 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.
Candidate Profile
* 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).
Desirable
* 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 07712412095