Overview
We are seeking a motivated and adaptable Clinical Research Associate II (CRA II) to join a growing clinical operations team within a collaborative and supportive environment. This role is ideal for an experienced CRA I looking to step into a CRA II position, an established CRA II, or a Senior CRA seeking the opportunity to work within a smaller, agile team structure.
The successful candidate will be responsible for monitoring clinical trial activities across multiple sites to ensure studies are conducted in compliance with protocol requirements, ICH-GCP guidelines, SOPs, and applicable regulatory requirements.
This position requires nationwide travel across the UK, with the potential for international travel in the future.
Key Responsibilities
- Perform site selection, initiation, monitoring, and close-out visits in accordance with study timelines and monitoring plans
- Build and maintain strong relationships with investigators and site staff
- Ensure patient safety, data integrity, and protocol compliance throughout all study phases
- Review source documentation and verify data entered into CRFs/eCRFs
- Identify, document, and escalate site issues, protocol deviations, and risks appropriately
- Support sites with study-related training and guidance
- Prepare monitoring visit reports and follow-up documentation within required timelines
- Collaborate cross-functionally with Clinical Operations, Project Management, Data Management, and other study teams
- Participate in internal meetings, investigator meetings, and presentations as required
- Maintain up-to-date knowledge of applicable regulations, SOPs, and industry best practice
Requirements
- Previous experience working as a CRA within the pharmaceutical, CRO, or biotech industry
- Suitable for:
- Experienced CRA I candidates ready for progression
- Existing CRA II professionals
- Senior CRAs interested in a smaller team environment
- Strong understanding of ICH-GCP and clinical trial processes
- Excellent communication and presentation skills
- Strong organisational and problem-solving abilities
- Ability to work independently and manage multiple priorities effectively
- Full willingness and ability to travel nationally on a regular basis
- Ability to attend quarterly office meetings
- Full UK driving licence preferred
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