UNIV - Program Coordinator II: Project Management Director - Department of Public Health Sciences

Medical University of South Carolina - Charleston, SC

Full-time - Mid Level

Charleston, SC

Educational Services

About the position

The Program Coordinator II will serve as the Project Management Director for assigned studies within the Data Coordination Unit (DCU) at the Medical University of South Carolina. This role focuses on overseeing project management activities for multicenter clinical trials, ensuring compliance with regulatory guidelines, and providing guidance to collaborators. The position requires strong leadership in managing study-specific procedures and maintaining high-quality trial conduct.

Responsibilities

• Serve as the Project Management Director for assigned DCU studies, overseeing all study-specific project management activities.
• Assess project management procedures with a focus on risk in accordance with FDA policies and ICH Good Clinical Practice guidelines.
• Lead the development of trial-specific procedures related to project management activities and responsibilities.
• Review program objectives to ensure compatibility with the agency's mission and propose policy or procedure changes.
• Prepare and present project management reports to the Operations Committee and respond to requests for information from the PI and sponsor.
• Direct and oversee study drug distribution, safety reporting, and the activities of external site monitors.

Requirements

• A bachelor's degree in a relevant field.
• Two years of relevant program experience.