Location: Gainesville, FL
Cap-Exempt H-1B Position — No lottery required
**JOB NO:** 539802 **WORK TYPE:** Staff Full-Time **LOCATION:** Main Campus (Gainesville, FL) **CATEGORIES:** Health Care Administration/Support **DEPARTMENT:** 29040100 - MD-ANESTHESIOLOGY-GENERAL **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:** Selects and recruits study participants to enroll in various studies and protocols; participates in the informed consent process of study subjects; supports the safety of clinical research patients/research participants; coordinates protocol-related research procedures, study visits, and follow-up care; screens, completes case report forms (paper & electronic data capture), and addresses queries. Documents investigational product (drug/device) accountability. Maintains and creates study source documents and electronic databases; reports adverse events; understands Good Clinical Practice (GCP) and regulatory compliance; educates subjects and family on protocols, study interventions, study drugs, etc.; complies with institutional policies, standard operating procedures (SOPs), and guidelines. Must comply with federal, state, and sponsor policies and manage essential regulatory documents. Acts as a liaison for research subject, investigator, IRB, sponsor, and heatlhcare professionals. Instructs healthcare team personnel (nurses, technicians, and students) regarding equipment operation, monitoring procedures, and patient care details associated with clinical studies. Develops in-service education programs as needed for clinical research. Develops advertisement materials. Aids in managing research volunteers involved their research projects. Summarizes conditions of patients and fills out data collection forms, which involves explaining procedures, protocols, and patient condition to patients and families. Researches regula