Clinical Research Associate (CRA)

About the Role

Our client, a leading pharmaceutical research organization, is seeking a detail-oriented and proactive Clinical Research Associate (CRA) to join their team in Plymouth . This role is crucial for overseeing and managing clinical trial activities to ensure the integrity of data and the safety of participants. You will be responsible for site selection, initiation, monitoring, and close-out visits, ensuring compliance with protocols, Good Clinical Practice (GCP), and regulatory requirements. The ideal candidate has a strong background in clinical research, excellent analytical skills, and the ability to travel regularly. This hybrid position offers the chance to contribute to groundbreaking medical advancements within the Devon area.

Key Responsibilities

• Conduct site visits (selection, initiation, monitoring, close-out) according to study protocols and regulatory guidelines.
• Ensure compliance with protocol, FDA regulations, ICH-GCP guidelines, and other applicable regulatory requirements.
• Verify the accuracy, completeness, and consistency of clinical data through source document review.
• Manage investigational product accountability and ensure proper storage and handling.
• Serve as the primary liaison between the sponsor and investigative sites, fostering strong working relationships.
• Prepare and present study progress reports, identifying and resolving site-specific issues promptly.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 2 years of experience as a Clinical Research Associate or equivalent experience in clinical trial management.
• Thorough understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent communication, interpersonal, and organizational skills.
• Willingness and ability to travel frequently to clinical sites within the Plymouth region and potentially further afield.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance.
• Company car or travel allowance.
• Opportunities for professional development and advanced training in clinical research.
• Contribute to vital research impacting healthcare in Devon and beyond.