Lead Clinical Research Associate

JR United Kingdom; Oxford; Remote; GBP 45,000 - 70,000; Full time

Job summary

A leading company in the clinical research sector is seeking a Lead Clinical Research Associate to oversee clinical trial sites and ensure compliance with regulatory protocols. This role involves site visits, monitoring activities, and collaboration with site staff to enhance trial integrity. Candidates should possess significant CRA experience and strong organizational skills, with a degree in a healthcare or scientific discipline preferred. This is a full-time, remote position offering a competitive salary.

Qualifications

• 4+ years of Clinical Monitoring/CRA experience in biotech, pharma, or CRO required.
• Strong knowledge of clinical trial processes, regulations, and GCP is essential.
• Excellent report writing and organizational skills necessary.

Responsibilities

• Oversee compliance with Monitoring Plan, protocol, GCP, and local regulations.
• Perform site qualification, initiation, monitoring, and close-out visits.
• Identify potential issues affecting subject safety and data integrity.

Skills

Clinical Monitoring

Regulatory Compliance

Organizational Skills

Communication Skills

Education

B.S. or healthcare/science degree

Tools

Microsoft Office

Project Management Tools

Clinical Trial Systems (EDC, IRT, CTMS, TMF)

Job description

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.