Location: Gainesville, FL
Cap-Exempt H-1B Position — No lottery required
**JOB NO:** 539463 **WORK TYPE:** Staff Full-Time **LOCATION:** Main Campus (Gainesville, FL) **CATEGORIES:** Health Care Administration/Support **DEPARTMENT:** 29141710 - MD-SURGERY-TCV-CARDIOVASC **CLASSIFICATION TITLE:** Clinical Research Coordinator I **CLASSIFICATION MINIMUM REQUIREMENTS:** Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience **JOB DESCRIPTION:** **Coordination of Protocol Subjects & Data Collection** - Performs subject screening and obtains consent for clinical protocols under the direction of the principal investigator. - Serves as a patient resource and educator regarding study information and clinical symptoms. - Prepares and ships central laboratory samples in accordance with protocol requirements. - Collects baseline and follow-up data from the medical record. - Documents findings in appropriate source records and case report forms. - Schedules and attends clinic appointments for patients, as required by protocol. - Communicates with nursing staff and OR staff regarding patient care in accordance with protocols. - Assists with operating room protocol requirements, as appropriate. - Records patient symptoms and adverse events in conjunction with care providers. - Reports and follows up on adverse events and serious adverse events, in consultation with the principal investigator, to the sponsor and Institutional Review Board, as required by protocol. **Coordination of Protocol Compliance** - Maintains knowledge of Good Clinical Practice guidelines and the Federal Code of Regulations regarding clinical trial conduct. - Coordinates and maintains HIPAA compliance for assigned studies. - Communicates with the interdisciplinary healthcare team involved in the care of patients participating in research studies to ensure regulatory compliance. - Interacts with local laboratories and diagnostic study centers to ensure clinical