Clinical Research Associate (CRA)

About the Role

Our client is looking for an experienced and meticulous Clinical Research Associate (CRA) to join their expanding clinical operations team in Newcastle upon Tyne . In this essential role, you will be responsible for ensuring the quality, integrity, and accuracy of clinical trial data by monitoring study sites, adhering strictly to protocol requirements, and maintaining compliance with GCP and regulatory standards. You will play a crucial part in the successful execution of clinical trials, contributing to the development of life-saving therapies. This hybrid position allows for a balance between on-site monitoring and remote administrative tasks.

Key Responsibilities

• Conduct site initiation, monitoring, and close-out visits according to study protocols and company SOPs.
• Verify the accuracy, completeness, and consistency of clinical data at investigational sites.
• Ensure compliance with ICH-GCP guidelines, local regulations, and study-specific procedures.
• Build and maintain strong working relationships with investigators, site staff, and study sponsors.
• Identify, resolve, and document site issues and deviations in a timely manner.
• Prepare and present monitoring visit reports and follow-up actions to site personnel and project management.

Requirements

• Bachelor's degree in Life Sciences, Nursing, or a related field.
• Proven experience as a Clinical Research Associate or similar monitoring role.
• Thorough understanding of ICH-GCP guidelines and clinical trial processes.
• Excellent communication, interpersonal, and organisational skills.
• Ability to travel to clinical sites as required, approximately 50% of the time.

Benefits

• Competitive salary commensurate with experience.
• Car allowance and travel expenses reimbursement.
• Comprehensive private medical insurance.
• Contributory pension scheme.
• Flexible working arrangements combining office and home-based work in Newcastle upon Tyne .