Clinical Research Associate

About the Role

Our client is seeking a diligent and experienced Clinical Research Associate (CRA) to join their expanding clinical operations team in Newcastle upon Tyne . This role is essential for overseeing and managing clinical trials, ensuring adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will be responsible for monitoring trial sites, data verification, and maintaining effective communication with investigators and study teams. This position offers a fantastic opportunity to contribute to the advancement of new therapeutics within a supportive and growth-oriented pharmaceutical company in the North East of England .

Key Responsibilities

• Conduct site initiation, monitoring, and close-out visits for clinical trials in accordance with study protocols and GCP.
• Verify the accuracy, completeness, and integrity of clinical trial data through source data verification (SDV).
• Ensure compliance with all applicable regulatory requirements, ethics committee approvals, and standard operating procedures (SOPs).
• Manage communication between clinical trial sites, study teams, and the sponsor.
• Identify and report deviations, risks, and issues, and implement corrective and preventive actions (CAPAs).
• Maintain trial master files (TMF) and ensure all study documentation is up-to-date and organized.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
• Minimum of 2 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
• Thorough understanding of GCP guidelines , regulatory requirements, and clinical trial processes.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent organizational, time management, and communication skills.
• Ability to travel to clinical trial sites as required, estimated at 50% travel.

Benefits

• Competitive salary commensurate with experience.
• Travel expenses fully reimbursed.
• Comprehensive health, dental, and vision insurance plans.
• Company car or car allowance provided.
• Opportunities for career advancement and professional development in clinical research.