Medical University of South Carolina UNIV - Program Coordinator II - Department of Medicine: Infection Diseases in Charleston, South Carolina
Job Summary: Under the direct supervision of the Research Nurse, the Program Coordinator will assist research investigators in the conduct of clinical research trials, including federally- and pharmaceutically-sponsored projects within the Division of Infectious Diseases.
35% - Assist with research study activities for the ID division including the coordination of patient related activities such as recruitment, obtaining informed consent, screening, scheduling and conducting study visits, and data collection. Collaborate with Principal Investigators to appropriately monitor adverse events and ensure timely reporting of events to study sponsors and the IRB. Act as a point of contact for patients enrolled in studies for matters relevant to the study. - (Essential)
30% - Perform clinical and laboratory tasks related to the ID procedures and study protocols. Coordinates or assits in data collection, management, and evaluation. Ensure study binders and case report forms are maintained as required by regulatory authorities and study sponsors. Coordinates site visits and communications with study sponsors, study monitors, and regulatory agencies. - (Essential)
15% - Assist with protocol review and the completion of clinic trial feasibility surveys. Review and provide coordination of research trial processes for principal investigators. Interact with research nurse, PIs, business manager, MUSC grants and contracts, and pharmacy staff in planning for, initiating, and maintaining study protocols. - (Essential)
15% - Assist with preparing study protocols for submission to the necessary regulatory offices. - (Essential)
5% - Maintain appropriate certifications and credentials. Conduct all research in adherence with the FDA Code of Federal Regulations "Good Clinical Practices" as well as MUSC IRB regulations. Other duties as assigned - (Essential)
Preferred Experience & Additional Skills:
A bachelor's degree and two years relevant program experience.