Clinical Study Coordinator

Clinical Study Coordinator supports a medical institution in clinical trial-related activities, coordinating tasks as determined by the Principal Investigator and local regulations. Responsibilities include evaluating study feasibility, conducting research visits, scheduling and testing per protocol, coordinating with ancillary departments for patient flow, data entry into study-related EDC systems, coordinating with CRO or sponsor for monitoring visits, mentoring staff, and performing administrative duties. The role involves facilitating communication between Milestone One, Sponsor/CRO, and the medical institution; contributing to recruitment/enrollment evaluation; assisting with tools and plans to improve recruitment/retention; obtaining informed consent; ensuring assessments and laboratory testing per protocol; coordinating sponsor/CRO visits; tracking recruitment targets; ensuring timely data entry and handling of adverse events and protocol deviations; managing investigational products and supplies, maintaining blinding when applicable; supporting regulatory submissions and site visits/audits; providing staff training and identifying improvement areas; and maintaining licensure/certifications. Education should include relevant experience coordinating clinical research studies involving human subjects (minimum two years); nephrology experience preferred. Certifications required include GCP, IATA, CPR, and phlebotomy, with preferred certification in clinical research (ACRP/SOCR A) that may be obtained within one year. Location is Tennessee with on-site duties at the Cleveland site and occasional travel to Athens and Chattanooga sites. This role emphasizes adherence to protocol, regulatory guidelines, and effective site coordination to meet enrollment targets.