University of Florida·Gainesville, Florida
Coordinate and execute clinical research activities within the Division of Pulmonary, Critical Care & Sleep Medicine. Manage clinical trial project lifecycles, including patient enrollment, regulatory documentation, and budget tracking.
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
This position serves as a member of the clinical research team, coordinating and completing assigned clinical research activities under the direction of the Principal Investigator and Assistant Director of Research. The incumbent will conduct clinical trials and clinical research within the Division of Pulmonary, Critical Care & Sleep Medicine, ensuring compliance with federal, state, and university policies, as well as Good Clinical Practice (GCP) guidelines and International Council for Harmonization (ICH) standards. This role requires strong organizational, problem-solving, communication, and regulatory compliance skills, with the ability to manage multiple projects simultaneously while maintaining accuracy and attention to detail.
Clinical Trial Regulatory Management
Prepare and submit institutional and regulatory documentation for study startup approval (IRB applications, CRN submissions, etc.)
Manage Institutional Review Board (IRB), Risk Assessment Committee (RAC), and sponsor submissions related to protocol amendments, safety reports, and compliance documentation
Ensure informed consent documents (ICF) are properly executed, documented, and filed; coordinate updates with IRB approval
Maintain comprehensive regulatory files in compliance with ICH-GCP, FDA 21 CFR Part 11, and UF policies
Respond to regulatory queries and document Corrective Action Requests (CARs) or audit findings; implement and track corrective actions
Ensure adherence to federal, state, and sponsor-specific compliance requirements (including HIPAA, FERPA, export control)
Archive study documents and maintain regulatory records per retention schedules post-study closeout
$53,000 - $69,700; Commensurate with education and experience
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
In order to be considered, you must upload your resume.
This requisition has been reposted. Previous applicants are still under consideration and need not apply.
55 p.m. (ET) of the posting end date.
Health Assessment Required: No
Market context
In Florida, Clinical Research Coordinator II roles in pulmonary research are typically tied to active clinical studies and hospital or academic research programs. Competition is often shaped by candidates who bring pulmonary-specific experience, clinical research coordination certification, and familiarity with protocol-driven patient visits, data collection, and regulatory documentation. This platform AI-summarizes the original job description’s requirements and benefits, helping you review fit faster; if you are applying, highlight any pulmonary research exposure and certification status in your materials.