Location: Gainesville, FL
Cap-Exempt H-1B Position — No lottery required
**JOB NO:** 539829 **WORK TYPE:** Staff Full-Time **LOCATION:** Main Campus (Gainesville, FL) **CATEGORIES:** Health Care Administration/Support **DEPARTMENT:** 29092100 - MD-CHILD HEALTH RES INSTITUTE **CLASSIFICATION TITLE:** Clinical Research Coord III **CLASSIFICATION MINIMUM REQUIREMENTS:** Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience. **JOB DESCRIPTION:** The Clinical Research Coordinator III position will join a team of coordinators that focuses on inherited muscular diseases. The Clinical Research Coordinator III will coordinate assigned clinical research studies under minor supervision while simultaneously working as part of the group mentioned above. The Clinical Research Coordinator III must be able to perform the following essential functions with minimal supervision: **Serve as primary study coordinator for clinical trial protocols as assigned:** Activities include but are not limited to: Onboarding new clinical studies following institutional workflows and requirements; Assisting PI and Clinical Research Manager with subject identification, recruitment, and enrollment. Takes primary responsibility for creation and maintenance of regulatory documents, including initial IRB submissions, continuing review submissions, and FDA and sponsor regulatory documents. Assists in the development of the study budget. Schedule, perform and or coordinate all study procedures / visits across all disciplines. Ensure that GCP is maintained throughout the length of the study. Host / prepare for external and internal audits (sponsor, FDA, NIH, IRB, etc.) Responsible for the protocol specific training of research and clinical staff involved in the study. Development of protocol specific case report forms as needed. Maintain and coordinate all aspects of complex study conduct, including data source documentation, adverse event reporting, and communication with the IRB / sponsor. Ensu