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

MUSC (Med. Univ of South Carolina)•Charleston, SC

47d

About The Position

The Program Coordinator II will serve as the Project Management Director for assigned DCU studies. The Data Coordination Unit, housed within the Department of Public Health Sciences (DPHS) at the Medical University of South Carolina, specializes in providing assistance with the design of clinical trials and analysis of their data and in establishing, implementing and maintaining data and project management systems for multicenter clinical trials. DCU Project Management Directors are responsible for overseeing all study-specific project management activities for their assigned trials. This includes, but is not limited to, overseeing all on-site monitoring activities, monitoring informed consent forms, ensuring regulatory documents are collected and maintained according to GCP guidelines, and leading internal monitoring meetings.

Requirements

A bachelor's degree and two years relevant program experience.

Nice To Haves

A bachelor's degree and at least two years relevant clinical research experience.
A master's degree in a related field is preferred.

Responsibilities

Serve as the Project Management Director for assigned DCU studies.
Direct, implement, oversee, and manage all study specific project management activities for assigned projects.
Provide comprehensive guidance and direction to collaborators pertaining to project management issues.
Assess project management procedures with a focus on risk in accordance with the FDA policies and guidance on centralized monitoring and ICH Good Clinical Practice guidelines, and implement changes to ensure high quality trial conduct.
Lead and direct the development of trial specific procedures related to Project Management activities and responsibilities.
Coordinate the development and maintenance of study specific documents, including, protocols, informed consent forms, and manual of procedures.
Review program objectives to determine compatibility with agency's mission; assess programs and propose policy or procedure changes.
Provide direction and guidance to staff concerning program issues.
Participate in the management of the assigned studies; attends planning sessions, recommend allocation of resources, provide feedback to employees and agency head.
Prepare and present project management reports to the Operations Committee as well as sponsor and federal agencies as requested.
Respond to requests for information from the PI and sponsor.
Direct and oversee study drug distribution, safety reporting, the collection of regulatory and essential documents, and the activities of external site monitors.