IRB RELIANCE MANAGER

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The IRB Reliance Manager will conduct timely regulatory reviews of proposed clinical trials to be conducted at Cooper that rely on an external Institutional Review Board (IRB), as well as studies in which Cooper will serve as the reviewing IRB for multi-site studies. The IRB Reliance Manager will ensure that such research upholds the ethical standards of Cooper University Healthcare, comply with Cooper SOPs, and other state or local considerations, while promptly reviewing materials in order to support clinical trial start-up. The IRB Reliance Manager will also be responsible for execution of reliance agreements, with appropriate support from the HRPP Director and Legal, when applicable.

Conduct independent, in-depth reviews of requests to rely (either requests for external sites to rely on Cooper IRB, or requests for the Cooper IRB to rely on an sIRB) and determine whether the requests are in accordance with Cooper policies and procedures.
Work with the Director of HRPP, Cooper Research leadership, and Cooper Legal to review, negotiate terms and facilitate the execution of IRB reliance agreements. Organize, track and maintain records of all reliance agreements and the covered research activities. Provide summary reports and metrics to the Director of the HRPP and Cooper leadership upon request.
Serve as the primary point of contact for Cooper investigators, research staff, external sites and Sponsors whenever the Cooper IRB will either rely on the review of an external sIRB or serve as the single IRB for other sites. Act as the liaison between Cooper investigators and others (e.g. external sIRBs, sponsors) to coordinate and implement reliance agreements.
Coordinate and oversee institutional responsibilities outlined in the agreements and/or dictated by federal, state or local laws and policies. This may include, but is not limited to, verifying training of the research team, reviewing consent forms for local context, reviewing financial disclosures for conflicts of interest, ensuring local ancillary reviews are completed, reviewing reports of unanticipated problems or suspected non-compliance.
With the Director of the HRPP, develop policies, procedures, and tools to facilitate and streamline the reliance agreement review process, local submissions, and the performance of institutional responsibilities and local review. Develop sIRB guidance documents, educational tools and templates for the Cooper research community. Conduct training of investigators and research staff on the use of sIRBs. Remain up-to-date on regulations and best practices in the field.
Perform administrative review of and processing of IRB submissions for research where the Cooper IRB is serving as the single IRB for external sites. Assists with regulatory review of submitted human research to the Cooper IRB, as needed.

3-5 years of experience

Bachelor's degree Preferred

Certified IRB Professional (CIP) Preferred

Communication - Ability to communicate with patients, visitors and coworkers
Knowledge of the Common Rule (45 CFR 46), FDA regulations, ICH Good Clinical Practice Guidelines, HIPAA Privacy Rule and other relevant requirements and guidelines related to the ethical study of human research subjects.
Proficiency in Microsoft Office Suite and other relevant software applications.
Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.