Location: Gainesville, FL
Cap-Exempt H-1B Position — No lottery required
**JOB NO:** 539472 **WORK TYPE:** Staff Full-Time **LOCATION:** Main Campus (Gainesville, FL) **CATEGORIES:** Office/Administrative/Fiscal Support, Grant or Research Administration, Health Care Administration/Support **DEPARTMENT:** 29190000 - MD-NEUROLOGICAL SURGERY **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:** **Research Coordination** - Coordinate clinical research studies and clinical trials in compliance with Good Clinical Practice (GCP) standards and other regulatory and legal requirements. - Screen and assist with the identification of research participants. - Obtain informed consent from study participants. - Schedule clinic visits and required testing for research participants. - Assist regulatory and research administration teams with preparation and management of IRB submissions. - Document investigational product (drug/device) accountability. - Create and maintain organized research study files and regulatory documentation. - Develop and manage research databases. - Perform accurate data entry and maintain study records. - Self-monitor and self-audit responsibilities. - Assist in the maintenance of ClinicalTrials.gov. - Develop case report forms (CRFs). - Trains junior coordinators and delegates (with supervisor approval) as appropriate. **Clinical Data Collection and Outcomes Reporting** - Collect and manage patient-reported outcomes (PROMs) and quality assurance data. - Track clinical outcomes for spine center programs and research projects. - Analyze data and prepare reports to measure program performance and effectiveness. - Develop and maintain dashboards and reporting tools to display outcomes data. - Serve as liaison for data-related projects between the clinic, referral teams, hospital partners, and other relevant teams. - Develop tools a