Clinical Research Associate

About the Role

Our client is seeking a dedicated Clinical Research Associate to join their dynamic clinical operations team based in Newcastle upon Tyne . This role is critical for ensuring the successful execution of clinical trials, upholding the highest standards of data integrity and regulatory compliance. You will be responsible for monitoring study sites, ensuring adherence to protocols, and managing relationships with investigators and study staff. This position offers an excellent opportunity to contribute to the advancement of medical treatments within a company that values patient safety and scientific rigor, working in a role that bridges laboratory research with patient care.

Key Responsibilities

• Conduct site initiation, interim, and close-out visits for clinical trials according to ICH-GCP guidelines.
• Monitor study conduct to ensure data accuracy, integrity, and patient safety at assigned clinical sites.
• Verify source documentation against case report forms (CRFs) and electronic data capture (EDC) systems.
• Train and support site staff on study protocols, procedures, and regulatory requirements.
• Liaise with investigators, site personnel, and internal project teams to resolve study-related issues.
• Prepare and submit monitoring reports in a timely and accurate manner.

Requirements

• Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
• Minimum of 3 years of experience as a Clinical Research Associate or equivalent monitoring role.
• Thorough understanding of ICH-GCP guidelines , FDA regulations, and other applicable regulatory requirements.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent organizational, communication, and interpersonal skills.
• Ability to travel to clinical sites as required, up to 50% of the time.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive health and wellness benefits package.
• Company car or travel allowance provided for site visits.
• Opportunities for career advancement and professional development within a growing organization.
• A supportive and collaborative work environment in Newcastle upon Tyne .