Title: Lead Clinical Research Associate
Full-time, permanent position
Location: UK-based, fully remote company
General Description:
The Lead Clinical Research Associate is a key team member responsible for overseeing a set of clinical trial sites within a region. They ensure compliance with the Monitoring Plan, protocol, Good Clinical Practice (GCP), and local regulations. They act as the primary contact for the site and liaise between the site and the client. Responsibilities include conducting site visits, overseeing document collection and review, and preparing monitoring reports.
Essential Functions:
* Perform site qualification, initiation, monitoring, and close-out visits (on-site or remote), ensuring regulatory, ICH GCP, protocol, and SOP compliance.
* Evaluate site performance and staff, providing recommendations for site-specific actions.
* Identify potential issues affecting subject safety and data integrity; escalate serious issues and develop action plans.
* Maintain knowledge of ICH/GCP guidelines, regulations, and SOPs.
* Verify informed consent processes and documentations.
* Conduct source document reviews and verify data entry compliance.
* Perform Source Data Review/Verification at assigned sites.
* Review investigational product inventory, reconciliation, and storage, ensuring GCP adherence.
* Review Investigator Site Files for accuracy and completeness.
* Contribute site and regional metrics for reporting.
* Manage site activities and communication to meet project goals.
* Ensure site and team training and compliance.
* Prepare for and attend Investigator and sponsor meetings.
* Support audit readiness and follow-up actions at sites.
Qualifications:
* At least 4 years of Clinical Monitoring/CRA experience in biotech, pharma, or CRO.
* B.S. or healthcare/science degree preferred.
* Strong knowledge of clinical trial processes, regulations, and GCP.
* Excellent report writing and document understanding skills.
* Strong organizational and communication skills.
* Ability to work in a fast-paced, dynamic environment and manage multiple tasks.
Technical Skills:
Proficiency with Microsoft Office, project management tools, and familiarity with clinical trial systems (EDC, IRT, CTMS, TMF) is advantageous.
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