Chief of Gyn-Oncology
Full-Time - 8am-5pm - Days, Monday-Friday - 40 Hours/Week
Abington Hospital - Jefferson Health
1200 Old York Road, Abington, PA 19001
The Regulatory Coordinator works under limited supervision and is responsible for the accurate compilation and submission of protocols and related study documents to the Protocol Review Committee (PRC) and applicable Institutional Review Board (IRB), as well as for maintaining regulatory study files to ensure all protocols and essential regulatory documents are current and complete.
Serves as the primary regulary contact for assigned protocols.
Maintains the regulatory binders/files and ensures appropriate version control is in place.
Coordinates submissions to ancillary committes, such as Radiation Safety and Institutional Biosafety.
Communicates with the IRB and sponsor on behalf of the study team regarding regulary management.
Collaborates with the study team and sponsors to finalize documents based on PRC and/or IRB recommendations.
Prepares and submits study amendments and continuing review applications for PRC and IRB review.
Prepares regulary files for auditing and monitoring visits.
Other duties as assigned.
Minimum of 2 years of clinical regulatory file management experience or Master’s degree and 1 year of clinical regulatory management experience.
Minimum of Bachelor’s degree required.
Abington Hospital – Jefferson Health is an equal opportunity employer, and our policy prohibits discrimination in employment because of race, creed, national or ethnic origin, gender, sexual orientation, age, disability, marital status, or veteran status.
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