MSD in the UK
Clinical Research Associate - Midlands
London
Posted 13 days ago
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Clinical Research Associate – South East (Midlands) (Travel Radio)
Introduction
- Location: Midlands (with 65–75% travel, ~2–3 days/week, domestic & international)
- Reporting To: CRA Manager or Clinical Research Director (CRD)
- Company:****Company – Upholding high-quality clinical research with ICH/GCP and local regulatory compliance
About the Role
We are seeking a highly skilled Clinical Research Associate (CRA) to lead performance and compliance for assigned clinical trial protocols across the South East. You will:
- Serve as the primary site contact throughout all trial phases.
- Ensure strict adherence to ICH/GCP, regulatory laws, company policies, and quality standards.
- Expand site networks, onboard new investigational sites, and drive subject matter expertise in monitoring.
- Collaborate globally while upholding patient safety, data integrity, and protocol compliance.
Key Responsibilities
Site & Trial Management
- Build and maintain relationships with investigators and sites across all trial phases.
- Select, validate, and onboard new sites; contribute to site selection decisions.
- Conduct remote and on-site monitoring to ensure:
- Data integrity (complete, unbiased, validated).
- Subject safety and rights protection.
- Adherence to protocol, SOPs, local laws, and regulatory guidelines.
- Execute validation, initiation, monitoring, and closure visits; document timely visit reports (clear, comprehensive).
Regulatory & Compliance
- Review and track regulatory documentation (start-up, maintenance, close-out).
- Monitor adverse events (AE) and ensure compliance with reporting requirements.
- Assess & resolve site performance gaps, deviations, and audits; escalate as needed ( collaborate CRA Manager → CRD → Regulatory Affair Teams).
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Cross-Functional Collaboration
- Partner with country operations, finance, regulatory, pharmacovigilance, legal, and regional teams.
- Engage with external stakeholders (CROs, IRB/IEC agencies, regulatory bodies).
- Aim to deliver site readiness (SRS) efficiently; streamline cross-module workloads.
Process Improvement & Mentorship
- Act as a SME in monitoring systems/processes; train juniors and conduct co-monitoring/quality control visits.
- Develop new site capabilities and mentor junior CRAs to drive retention.
- Investigate root causes of non-compliance/poor performance; implement preventive/corrective actions.
Travel Requirements
- 65–75% travel (~2–3 days/week), covering domestic and international sites.
- Preferred: Valid driver’s license (mandatory in certain locations).
Requirements
Core Qualifications
- Bachelor’s degree (or higher) with direct bio/pharma/CRO site monitoring experience.
- Varied exposure to multinational trials, drug/device research, and randomized studies.
- Proven ability to identify site-type risks and manage high-priority projects.
Technical Skills & Knowledge
- Expertise in ICH/GCP, IRL 3.1, Ira standards and all clinical trial phases.
- GDP/GDP/GIM compliance, investigator site aggressiveness, and study facilitation.
- IT proficient in MS Office + clinical trial management/reporting tools (DM/Center/CRF)—ability to adopt systems.
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Behavioral & Soft Skills
- Leadership: Held visible monitoring positions for new territories.
- Communication: Ability to explain regulatory/data challenges clearly.
- Drive: Enthusiasm to see trials through, even under tight timelines.
Preferred Experience
- Roles involving investigator contractor relations (next-of-kin agreements).
- Class ollutarship in managing ICH-E6, ethics committees, protocol amendments.
- Experience with OPQL vapour reporting, eTMF tools, and government submissions.
What We Offer
🔹 Impact: Shape high-performing development programs and expand future sites. 🔹 Growth: Mentorship, quality training, and guidance to build career retail trip activities. 🔹 Reward: Competitive compensation package + full benefits.
How to Apply
Submit CV and a cover letter outlining:
- Relevant monitoring track record (for 1–2 trials, including success CRF authors, training).
- Leadership in site troubleshooting (e.g., adoption rates).
Application Notes
- No recruitment consultants: No via third-party recruiters (orphans/ttar).
- Deadline: 07/12/2026 (submit by 11:59 PM the night before).
Additional Details
- Timeframe: Full-time, Permanent (Regular)
- Flex: Remote + flexible schedules
- VISA Sponsorship provided
- Equipment: Company devices/unless operating in a hazard-zone setting.
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Skills
Clinical Research Methods
Clinical Site Management
Clinical Study Management
Clinical Trial Planning
Clinical Trials
Clinical Trials Monitoring
Good Clinical Practice
Protocol Adherence
Regulatory Compliance
Location