Job Title: Clinical Research Associate (CRA) – Part-Time Consultant / Contractor
Location: United Kingdom (with regional travel to study sites in the UK and EU)
Contract Type: Part-Time Consultancy / Freelance Contract
Study Area: Colorectal Cancer
Overview
We are seeking an experienced Clinical Research Associate (CRA) level consultant to provide supplemental on-site and remote oversight in addition to CRO monitoring activities. This role will act as an extension of the sponsor’s team, ensuring compliance with protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.
The position will focus on targeted, high-value oversight activities at clinical sites to safeguard data integrity, patient safety, and study compliance.
Key Responsibilities
• Perform targeted on-site visits to verify protocol adherence, data accuracy, and correct handling of biological samples, with emphasis on high-risk procedures and critical endpoints.
• Observe study conduct and review source documentation to confirm appropriate sample processing and chain-of-custody.
• Escalate potential compliance or data quality risks to the sponsor in real time.
• Act as a liaison between site staff, the sponsor, and CRO monitors to facilitate timely issue resolution.
• Apply lessons learned from prior studies to proactively identify and mitigate operational risks.
• Document all oversight activities in accordance with sponsor quality management procedures.
• Contribute to ongoing risk assessments throughout the course of the study.
Preliminary Study Details
• UK Sites: 3 to 4
• Enrollment: 3 to 5 patients per site
Requirements
• Proven experience as a CRA, ideally with both on-site and remote monitoring exposure in the EU and UK.
• Strong working knowledge of ICH GCP, clinical trial regulations, and sponsor oversight practices.
• Excellent communication skills in English, including written, spoken, and reading comprehension.
• Ability to work independently while maintaining a high level of communication with the sponsor team.
• Flexible to occasionally work US East Coast hours to align with the sponsor’s team.
• Willingness and ability to travel regionally within the UK and EU.
• Experience in colorectal or similar therapeutic areas is preferred.
Contract Details
• Part-time, time and materials basis.
• Travel up and down the UK
• Engagement length and hours to be agreed upon based on study needs.
Note
This role is currently in the pipelining stage. We are confident that feedback will be received in the coming weeks, enabling engagement with suitable talent promptly thereafter.
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