About this role
Job Description
Leads the daily operations of the Radiology IND/IDE Support Office, supporting active and pending domestic and international INDs and IDEs. Oversees sponsor-investigator research involving investigational drugs and medical devices, serving as the liaison with the FDA to ensure compliance with regulatory requirements, GCP, institutional policies, SOPs, and Trial Master File maintenance. Directs risk-based monitoring activities, protocol and CRF review, and study monitoring to ensure subject protection, data integrity, and regulatory compliance. Manages a team of fewer than 10 staff supporting departmental investigators and collaborates extensively with faculty, researchers, and senior leadership across Radiology, the Perelman School of Medicine, and the Office of Clinical Research.
Job Responsibilities
- Responsible for leading the daily operations of the Radiology IND/IDE Support Office, which supports and oversees several active and pending INDs and IDEs within the department. Oversees research operations involving investigational drugs and medical devices where the Department of Radiology is the sponsor, acting as a liaison between the department and the FDA to ensure compliance with FDA regulations, institutional policies, Good Clinical Practice (GCP), institutional standard operating procedures, and the maintenance of appropriate Trial Master Files.
- Responsible for the development and implementation of risk-based study monitoring plans, review of protocols and case report forms to ensure the rights and well-being of human subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the study is compliant with the currently approved protocol, GCP, and all applicable regulatory requirements.
- Will also be responsible for the timely execution of study-specific monitoring visits and completion of monitoring reports under the direction of OCR Compliance. Manages a staff of