Clinical Research Associate (CRA) - Phase II/III

About the Role

Our client is looking for a dedicated and thorough Clinical Research Associate (CRA) to join their clinical operations team in Edinburgh . In this role, you will be responsible for monitoring clinical trial sites to ensure adherence to protocols, Good Clinical Practice (GCP), and regulatory standards. You will play a critical part in the successful execution of Phase II and III studies, ensuring data accuracy and patient safety. This hybrid position combines remote monitoring activities with essential on-site visits to study centers.

Key Responsibilities

• Conduct site initiation, interim, and close-out visits according to study protocols and GCP guidelines.
• Monitor study conduct and ensure data is collected, recorded, and reported accurately and efficiently.
• Verify the rights and well-being of human subjects participating in clinical trials.
• Manage study site relationships, providing training and support to site staff.
• Ensure all documentation is maintained in compliance with regulatory requirements and company SOPs.
• Identify and resolve site-level issues and deviations promptly.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 2 years of experience as a Clinical Research Associate or equivalent monitoring role.
• Strong knowledge of ICH-GCP guidelines and relevant regulatory requirements.
• Experience with Phase II and/or Phase III clinical trials.
• Excellent organizational, communication, and interpersonal skills.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.

Benefits

• Competitive salary with potential for performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Car allowance and reimbursement for travel expenses.
• Opportunities for professional development and training.
• Flexible hybrid work arrangement.