Regulatory Specialist
About The Position
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. The incumbent will ensure studies remain audit-ready at all times and support monitoring visits, audits, and inspections. The CRC II will collaborate closely with investigators, sponsors, and research teams to facilitate efficient study activation and maintenance. While this role has a regulatory focus, cross-functional support of study coordination activities—including participant screening, consent, and visit coordination—may be required as needed.
Requirements
- Bachelor's degree in an appropriate area
- Two years of relevant experience; or an equivalent combination of education and experience
- Demonstrated experience in clinical trial regulatory management, including industry-sponsored and grant-funded studies
Nice To Haves
- Master’s degree or allied health professional degree in an appropriate area
- Minimum of 2–3 years of regulatory experience in clinical research, including industry-sponsored trial submissions
- Demonstrated experience submitting to and managing studies with central IRBs (e.g., WCG, Advarra) and local IRBs
- Experience supporting both industry-sponsored and grant-funded (investigator-initiated or federally funded) studies
- Proven ability to prepare and manage regulatory documents, including initial submissions, amendments, continuing reviews, safety reports, and study closeouts
- Strong communication skills
- Ability to prioritize in a fast-paced environment
- Knowledge of HIPAA, Good Clinical Practice (GCP), and research systems such as EPIC, UFIRST, OnCore, REDCap, or similar platforms
Responsibilities
- Support regulatory operations across multiple clinical trials, with a strong emphasis on study start-up, submissions, and ongoing compliance
- Lead and coordinate submissions to central and local Institutional Review Boards (IRBs)
- Ensure all regulatory documents are complete, accurate, and compliant with federal regulations, sponsor requirements, and institutional policies
- Prepare and maintain regulatory binders and essential documents
- Submit new studies, amendments, continuing reviews, and reportable events
- Serve as a primary liaison between sponsors, IRBs, and internal stakeholders
- Ensure studies remain audit-ready at all times
- Support monitoring visits, audits, and inspections
- Collaborate closely with investigators, sponsors, and research teams to facilitate efficient study activation and maintenance
- Provide cross-functional support of study coordination activities—including participant screening, consent, and visit coordination—as needed
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1-10 employees
