HRPP Assistant Director, External Collaborations & IRB Reliance

Department
 

BSD OCR - Human Subjects Protection

About the Department
 

The Office of Clinical Research (OCR) was created to further the research missions of the University of Chicago Biological Sciences Division and the University of Chicago Medical Center. The office’s mission is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that
facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection. To do this, the work of the OCR is supported by five service units: Human Subject Protection (IRB); Research Compliance; Clinical Research Operational Excellence; Clinical Research Incubation; and Clinical Trial Finance.

Job Summary
 

The Assistant Director manages a team of professional staff responsible for regulatory compliance program activities. Anticipates problems and develops systems to identify areas of risk through internal audits. Uses specialized expertise to manage compliance documentation submission and maintenance, compliance training, compliance committee formation, and other programmatic functions. Assistant Director will be responsible for managing the reliance process and relationships between the University of Chicago and outside/external IRBs. Design, implement and manage the reliance agreement process.

Responsibilities

​For studies in which UChicago is the relying IRB:

• Review and manage requests from UChicago BSD investigators to rely on an external IRB, determine eligibility for reliance and communicate reliance determinations to the PI/study team.

• Ensure that all BSD institutional requirements for human subjects research, such as billing and budgetary review, are completed and relevant information provided to the reviewing IRB.

• Serve as an administrative reviewer to complete institutional review of external IRB applications.

• Serve as liaison with reviewing IRB for IRB and study related matters including questions related to institutional requirements and local context.

For studies in which UChicago is the reviewing IRB:

• Review and manage requests from external organizations/investigators to rely on the BSD IRB, determine eligibility for reliance and communicate reliance determinations to the PI/study team.

• Review application and related documents submitted by relying sites to assure that all required information has been submitted.

• Ensure that all external site institutional requirements for human subjects research, such as site ancillary committee review and site departmental administrative reviews, are completed prior to release of BSD IRB approval for that site.

• Work with Research Subjects Specialist to ensure efficient review and help coordinate approval notices and related documents.

• Serve as the liaison with the relying IRBs for IRB and study related matters.

Reliance Program Administration:

• Serve as the primary point of contact for single IRB review and reliance/master agreement.

• Serve as the liaison between UChicago legal counsel and the external sites to coordinate the finalization and execution of Reliance/Master Agreements.

• Act as a liaison to facilitate reliance relationships through national reliance initiatives.

• Work with the IRB Directors, IRB Chairs and IRB staff to identify and resolve problems and improve efficiency and effectiveness of IRB reliance process.

Other:

• Serves as key liaison between the BSD IRB, Principal Investigators (PIs), clinical study sites, individual study teams and external organizations and IRBs regarding IRB reliance issues.

• Work with University Research Administration and legal counsel to address legal and Institutional requirements related to reliance agreements and the reliance process.

• Develop policies, guidelines and procedures related to IRB reliance when the University of Chicago is serving as the reviewing IRB or the relying IRB.

• Provide analytical and administrative support to the UChicago IRB related to IRB reliance.

• Provide phone and in-person consultation to UChicago BSD investigators inquiring about the reliance agreement process.

• With the HRPP Director, IRB Director and others, work with IT Services to improve the electronic application submissions, both for when UChicago is the reviewing IRB and institution is relying upon an external IRB.

• Provide training and education for PIs, study teams, IRB members and others on the IRB reliance process.

• Develop and enhance policies, procedures, tools, and educational materials designed to facilitate and streamline practice