Senior Regulatory and Compliance Officer

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Job Title:

Senior Regulatory and Compliance Officer

Department:

Medicine | Psychiatry

The Senior Regulatory Compliance Officer assists the Regulatory Compliance Lead, with the oversight and monitoring of the regulatory research compliance function across the research center with support from the Associate Director, Operations C4N for projects being conducted in C4N and serves as a subject matter expert, coordinates and guides the review and approval process for complicated research protocols with a focus on investigator-initiated and federally funded protocols; provides regulatory expertise to ensure research protocols are in compliance with university, state and federal regulations; develops and prepares complex protocol submissions to local and national Institutional Review Boards (IRB); serves as a unit resource for development of IRB documents and for guidance on IRB communications which includes participation in mentoring and training activities; oversees and ensures timely submission of protocol documents for review by appropriate agency; communicates with sponsors of industry, federal, collaborative, and investigator-initiated research projects to address concerns and ensure compliance; establishes and oversees tracking system to continually monitor progress of protocol review and status of approval and ensures regulatory submission timelines are met; manages regulatory data entry into the OnCore database, if applicable; participates in the creation and delivery of onboarding and educational training programs, tools and materials; continually monitors federal and sponsor rules, regulations and processes to identify and interpret new, updated or changed requirements; provides regulatory updates to investigators and research staff of new or changed regulations; leads the development of and provides required regulatory reports and associated documentation; engages in regular monitoring of regulatory files in conjunction with investigators and research staff; conducts audits with special emphasis on investigator-initiated and federally funded protocols.

Minimum Education and Skills/Experience Required/Desired: Bachelor's degree or equivalent experience. Advanced degree in relevant field may be desirable. 4 years of relevant experience required. 4-8 years of relevant experience preferred. Knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required; experience and knowledge of federal & industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical or research setting desired; experience in protocol development desired. Requires successful completion of a background check. Selected candidate may be requested to complete a pre-employment physical including a drug screen

Additional Information:

Location:

Research Administration Building (0200)

Position Type:

Regular

Scheduled Hours:

40

Shift:

First Shift

Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.

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The university is an equal opportunity employer, including veterans and disability.

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