Clinical Research Associate à Grande-Bretagne

Client: Hlx Life Sciences

Location: Woking, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views: 3

Posted: 06.06.2025

Expiry Date: 21.07.2025

The Lead Clinical Research Associate is a key team member responsible for overseeing clinical trial sites within a region. They ensure compliance with Monitoring Plan, protocol, GCP, and local regulations. Responsibilities include conducting site visits, managing documentation, and acting as the primary liaison between sites and the client.

• Perform site qualification, initiation, monitoring, and close-out visits, ensuring compliance with regulations and SOPs.
• Evaluate site performance and provide recommendations.
• Identify and escalate issues affecting subject safety and data integrity.
• Maintain knowledge of GCP guidelines and regulations.
• Verify informed consent processes and documentations.
• Conduct source data review and verify site compliance with data entry requirements.
• Review inventory, reconciliation, and storage of investigational products.
• Review Investigator Site Files for accuracy.
• Provide metrics and support project reporting.
• Manage site activities to meet project objectives and timelines.
• Ensure training and compliance of site staff.
• Prepare for and attend meetings with investigators and sponsors.
• Support audit readiness and follow-up actions.

• Minimum 4 years of Clinical Monitor/CRA experience in biotech, pharmaceutical, or CRO.
• B.S. or healthcare/science degree preferred.
• Strong understanding of clinical trial processes and GCP.
• Excellent report writing and document comprehension skills.
• Organizational and communication skills.
• Ability to work in a fast-paced environment and manage multiple tasks.

Proficient in Microsoft Office, familiar with clinical trial systems such as EDC, IRT, CTMS, and TMF platforms is a plus.