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The Weill Cornell Medicine Human Research Protection and Compliance department is expanding! More positions will be posted soon.
NOTE: This job is listed as "IRB Regulatory Supervisor" on the Weill Cornell Medicine careers page.
Reporting to the Assistant Director for IRB operations, the team manager is responsible for leading, managing, and oversight of the Expedited IRB regulatory team, all aspects of IRB operations and provides consultation for the development of research protocols to investigators utilizing human subjects. This position is also an active member of the Institutional Review Board (IRB) and performs review duties as appropriate.
Conduct review of research protocols and make non-human subject research determinations, Exempt determinations and Expedited review determinations.
Ensures that IRB members consider necessary regulatory requirements and considerations in their review of protocols.
Manages the regulatory review of IRB submissions. Determines level of review and board and regulatory associate assignment. Is the point person for staff with escalated reviews.
Serves as the subject matter expert surrounding IRB regulatory requirements, processes and procedures. Ensures timely processing of IRB reviews. Responsible for reviewing select expedited submissions.
Facilitates IRB meetings, as necessary, to ensure efficiency and compliance. Ensures appropriate action items and minutes are compliant with relevant OHRP and FDA regulations.
Participates and presents at educational workshops and trainings as needed.
Assists with the development of standard operating procedures.
Other duties as assigned.
Practical knowledge of the federal and industry regulations that govern human subject's research.
Must be able to make regulatory determinations: non-human subject research determinations; Exempt determinations; expedited review categories
Internal Number: REQ Number 29705
About Weill Cornell Medicine (Weill Cornell Medical College)
Weill Cornell Medicine is committed to excellence in patient care, scientific discovery and the education of future physicians in New York City and around the world. The doctors and scientists of Weill Cornell Medicine—faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and Weill Cornell Physician Organization—are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies. Located in the heart of the Upper East Side's scientific corridor, Weill Cornell Medicine's powerful network of collaborators extends to its parent university Cornell University; to Qatar, where an international campus offers a U.S. medical degree; and to programs in Tanzania, Haiti, Brazil, Austria and Turkey. Weill Cornell Medicine faculty provide comprehensive patient care at NewYork-Presbyterian/Weill Cornell Medical Center, NewYork-Presbyterian/Lower Manhattan Hospital and NewYork-Presbyterian/Queens. Weill Cornell Medicine maintains major affiliations with Memorial Sloan-Kettering Cancer Center, The Rockefeller University, the Hospital for Special Surgery and Houston Methodist. ...Weill Cornell Medicine is accredited by the Liaison Committee for Medical Education of the American Medical Association and the Association of American Medical Colleges.