Manager, Expedited IRB Team

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.