Regulatory Specialist

Job description

Classification Title: Clinical Research Coordinator II Classification Minimum Requirements: Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience. Job Description: The Clinical Research Office (CRO) within the Office of Research Affairs (ORA), Dean’s Administration, College of Medicine–Jacksonville, is seeking a Clinical Research Coordinator II (Regulatory Focus) with demonstrated experience in clinical trial regulatory management, including industry-sponsored and grant-funded studies. This role is responsible for supporting regulatory operations across multiple clinical trials, with a strong emphasis on study start-up, submissions, and ongoing compliance. The CRC II will lead and coordinate submissions to central and local Institutional Review Boards (IRBs), ensuring all regulatory documents are complete, accurate, and compliant with federal regulations, sponsor requirements, and institutional policies. Key responsibilities include preparation and maintenance of regulatory binders and essential documents, submission of new studies, amendments, continuing reviews, and reportable events, and serving as...