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

$46,655 - $86,321/Yr

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 Data Coordination Unit (DCU) studies at the Medical University of South Carolina. This role involves overseeing project management activities for clinical trials, ensuring compliance with regulatory standards, and leading internal monitoring efforts. The position is crucial for maintaining high-quality trial conduct and providing guidance to collaborators.

Responsibilities

• Serve as the Project Management Director for assigned DCU studies, overseeing all study-specific project management activities.
• Assess project management procedures focusing 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 for 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 collection of regulatory documents.

Requirements

• Bachelor's degree in a relevant field.
• Two years of relevant program experience in clinical trials.