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Lead Clinical Research Associate, Portsmouth, Hampshire

Client: Hlx Life Sciences

Location: Portsmouth, Hampshire, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views: 3

Posted: 06.06.2025

Expiry Date: 21.07.2025

Job Description:

Title: Lead Clinical Research Associate

Position: Full-time, permanent

Location: UK-based, fully remote company

General Description:

The Lead Clinical Research Associate oversees a defined set of clinical trial sites, ensuring compliance with monitoring plans, protocols, GCP, and local regulations. They act as the primary contact for sites and coordinate monitoring activities, including site visits, document review, and reporting.

Essential Functions:

• Conduct site qualification, initiation, interim monitoring, and close-out visits, on-site or remotely, ensuring compliance with regulations and SOPs.
• Evaluate site performance and provide recommendations for improvement.
• Identify and escalate issues affecting subject safety or data integrity.
• Maintain knowledge of GCP guidelines, regulations, and SOPs.
• Verify informed consent processes and documentations.
• Review source documents and verify data entry compliance.
• Perform source data review and verification.
• Review investigational product inventory, reconciliation, and storage.
• Review Investigator Site Files for accuracy.
• Contribute to project metrics and reports.
• Manage site activities, communication, and ensure training and compliance.
• Prepare for and participate in investigator and sponsor meetings.
• Support audit readiness and follow-up actions.

Qualifications:

• At least 4 years of Clinical Monitor/CRA experience in biotech, pharma, or CRO.
• B.S. or healthcare/science degree preferred.
• Strong knowledge of clinical trial processes, ICH GCP, and regulations.
• Proven report writing and document review skills.
• Excellent organizational and communication skills.
• Ability to work in a fast-paced environment and manage multiple priorities.

Technical Skills:

Proficiency in Microsoft Office, project management tools, and familiarity with clinical trial systems like EDC, IRT, CTMS, TMF is a plus.