Clinical Research Coordinator III
Oncology Service Line Administration
Full-Time - Day Shift - 40 Hours/Week
Asplundh Cancer Pavilion
3941 Commerce Avenue, Willow Grove, PA 19090
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 regulatory contact for assigned protocols.
Maintains the regulatory binders/files and ensures appropriate version control is in place.
Coordinates submissions to ancillary committees, such as Radiation Safety and Institutional Biosafety.
Communicates with the IRB and sponsor on behalf of the study team regarding regulatory 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 regulatory files for auditing and monitoring visits.
Other duties as assigned.
Education: Minimum of bachelor's degree.
Experience: Minimum of 2 years of clinical research experience, or Master's degree and 1 year of clinical research experience.
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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