Research Agreement Specialist

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Research Agreement Specialist

Duties: Reporting directly to the Associate Director for Operations (the Associate Director ) of the Human Research Protection Office at University, the Research Agreement Specialist assists the Associate Director and the Office staff in the review of certain research agreements. Providing administrative and regulatory support to the University Institutional Review Boards in the review and oversight of research that involves human subjects. Will work with the Associate Director to review (a) agreements through which IRB review is ceded to University by another institution or by CU to another institution ( Reliance Agreements ) as they relate to the Board policies and procedures, and (b) agreements that pertain to University’s receipt, storage or transfer of specimens and data to ensure consistency with IRB protocols or to determine that an IRB protocol is not required ( Ancillary Agreements and , together with Reliance Agreements, Agreements ). All reviews are preliminary to review by the University office with signatory authority for the respective agreement. Collaborates with the Associate Director, the Executive Director of the HRPO, the Office of the General Counsel, Sponsored Projects Administration ( SPA ), the Clinical Trials Office ( CTO ), the Privacy Office ( Privacy ) and faculty in meeting the institutional needs regarding review and execution of the Agreements. Liaises with internal research administration partners such as SPA, the CTO, Privacy and the Office of Research Compliance and Training. Works with HRPO staff to draft and communicate requirements to researchers with respect to revising IRB submissions such that requirements of Ancillary Agreements are met. Works closely with the Associate Director to communicate University policies and procedures to institutions that may cede IRB review to University or to which University may cede IRB review. Assists the Associate Director in developing and implementing policies and procedures designed to facilitate efficient and effective processing of the Agreements within the Office. Functions as primary contact within the HRPO for the researcher and internal partners with respect to status the Agreement review process. Other duties as required, including research on state laws or other regulatory requirements that pertain to research involving human subjects or IRB review of such research.

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