Regulatory Coordinator

Job description

Clinical Research Regulatory Coordinator About the Role: We are seeking a Clinical Research Regulatory Coordinator (CRRC) who is enthusiastic about clinical research and thrives in a team environment. The Clinical Research Regulatory Coordinator will be responsible for maintaining clinical trial regulatory documents and ensuring all sites adhere to the ICH-GCP guidelines and site operating procedures. The CRRC will also assist with the maintenance of staff documentation and site-specific certifications. The successful applicant will be extremely organized, can communicate effectively with multiple clinical research staff, collaborate with external vendors, and enjoy working in a dynamic work environment. What You’ll Be Doing: - Organize and maintain study documents - Oversee staff and site related documentation and certifications - Ensure regulatory compliance by all sites to ICH-GCP guidelines and site operational procedures - Prepare site for regulatory inspection - Submit continuing review reports - Submit new study IRB submissions - Travel to U.S. Urology Sites to review Regulatory - Work with Operational Support Specialist during study start-up to provide all necessary documen...