UNIV - Regulatory Coordinator - Department of Medicine: Division of Pulmonary

Job Description Summary This position will serve as the Regulatory Coordinator for the Clinical Trial Research Program specializing in Pulmonary, Critical Care, Gastroenterology, Endocrinology Nephrology and Hepatology. This position will work with the Program’s Clinical Research Coordinators and Clinical Research Program Manager to ensure all deadlines are met. Responsibilities include coordinating and performing study specific regulatory processes for the Program while ensuring that appropriate regulations and Standard Operating Procedures (SOPs) are followed. Entity Medical University of South Carolina (MUSC - Univ) Worker Type Employee Worker Sub-Type​ Research Grant Cost Center CC000974 COM DOM PULM General CC Pay Rate Type Hourly Pay Grade University-GEN08 Pay Range 46,206.00 - 62,322.00 - 78,540.000 Scheduled Weekly Hours 40 Work Shift Day (United States of America) Job Description Job Duties: 25% - Study Start-up and Maintenance: Receive start-up packet from sponsor; initiate and monitor study start-up activities, including all necessary documents. Upon activation, submit amendments and any changes to the study to the IRB and notify study team of all approvals. Submit continuing reviews. Answer questions and provide documents as requested by the Investigator, Program Manager, and study sponsor. Maintains accurate study registration as applicable (ClinicalTrials.gov, etc) for all investigator-initiated projects; provides guidance on issues such as when to re-consent su