at University of Chicago in Chicago, Illinois, United States
Job Description
DepartmentBSD 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 practices related to the reliance agreement review process, institutional responsibilities, and local review as applicable.
- Coordinate with senior leadership to develop UChicago policies and procedures related to collaborative human research activity, including research involving sites within the UChicago health system, as well as external and affiliate sites.
- Participate in an evaluation and strategic planning and formulation of short- and long-term goals and objectives.
- Interact with federal and state regulatory agencies, such as the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Office for Human Research Protections (OHRP) regarding IRB reliance issues and provide regulatory guidance to IRB members and staff as needed.
- Mentor and manage Regulatory Compliance Administrator(s) specializing in reliance activities.
- Ensures teams develop and administer policies related to affirmative action, non-discriminatory practices for persons with disabilities, and unlawful harassment or sexual misconduct.
- Manages the implementation of compliance activities designated by the University's strategic plans. Monitors University compliance with regulations and laws.
- Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
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Work Experience:
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.
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Certifications:
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Preferred Qualifications
Education:
- Bachelor's degree.
Experience:
- Two or more years of relevant work experience as an IRB administrator strongly preferred.
- Five years' experience working in the human subjects' research area.
Preferred Competencies
- Knowledge of human subjects research ethical principles, regulations, policies and procedural requirements of institutional review boards.
- Demonstrated ability to work independently, exercise sound judgment and multi-task.
- Ability to communicate in a professional, positive and persuasive manner.
- Strong administrative/coordination/project management skills.
Working Conditions
- Office Environment.
Application Documents
- Resume (required)
- Cover Letter (preferred)
When applying, the document(s) MUSTbe uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Legal & Regulatory Affairs
Role Impact
People Manager
FLSA Status
Exempt
Pay Frequency
Scheduled Weekly Hours
40
Benefits Eligible
Yes
Drug Test Required
No
Health Screen Required
No
Motor Vehicle Record Inquiry Required
No
Posting Statement
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at:http://securityreport.uchicago.edu.Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
