Lead Clinical Research Associate

JR United Kingdom; Woking; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in the life sciences sector is seeking a Lead Clinical Research Associate to oversee clinical trial sites in Woking. This position involves ensuring compliance with policies and regulations, conducting site visits, and managing documentation. Ideal candidates will have significant CRA experience, strong organizational skills, and the ability to thrive in dynamic environments.

Qualifications

• 4+ years of Clinical Monitor/CRA experience in biotech, pharmaceutical, or CRO.
• Strong understanding of clinical trial processes and GCP required.
• Ability to manage multiple tasks and work in a fast-paced environment.

Responsibilities

• Oversee clinical trial sites ensuring compliance with regulations.
• Conduct site visits, manage documentation, and liaise with clients.
• Evaluate site performance and escalate issues affecting safety.

Skills

Organizational skills

Communication skills

Report writing

Document comprehension

GCP understanding

Education

B.S. or healthcare/science degree

Tools

Microsoft Office

EDC

IRT

CTMS

TMF platforms

Job description

Lead Clinical Research Associate, Woking

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

Job Description:

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.

Essential Functions:

• 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.

Qualifications:

• 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.

Technical Skills:

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