Description

The Department of Surgery is seeking to hire a full time Regulatory Coordinator to coordinate and participate in all regulatory research activities. In this role you will work with the PI, Sub-Investigators, research personnel and hospital staff (collectively, the Study Team) to serve as Regulatory Coordinator for investigator-initiated and sponsor-initiated clinical trials and clinical research projects funded by industry-sponsors, federal and state agencies, and other non-profit foundations and organizations.

You will be responsible for:

• preparing, managing and submitting any required study/regulatory documents, and all required applications and forms
• submissions to the applicable Institutional Review Board (IRB), informed consent form development, required contractual and/or grant related documents, investigational pharmacy applications, other ancillary services applications, FDA IND/IDE/510k/SAE/MedWatch applications and submissions, etc.
• analytical and problem-solving skills to address and resolve potential issues as they arise.
• working with study monitors to process, review, and collect appropriate regulatory documents in a timely manner.
• Willingness to work flexible hours and/or overtime to meet study deadlines and requirements.