| Essential Functions |
- Attains and maintains comprehensive and up-to-date knowledge of human subject research protections and Institutional Review Board (IRB) regulations as contained in 45 CFR 21 CFR 50 & 52, and other applicable regulations.
- Serves as the subject matter expert by providing guidance and training to researchers, faculty, staff, students, and IRB members.
- Oversees the day-to-day administrative operations of the IRB submission, review, and approval process.
- Ensures compliance, high quality review, and efficiency in IRB operations.
- Manages all aspects of IRB committee meetings, including ensuring adequate meeting attendance to conduct meetings, reviewer assignments, staff support, technical support, agenda creation, meeting minutes, and supporting the IRB chair in managing the meeting.
- Manages the IRB reliance program, including tracking of reliance agreements and procedures for reliance through various organizations and mechanisms, including review and oversight of collaborative research with the University.
- Oversees the continued expansion and streamlining of the reliance processes.
- Analyzes and reviews applications for the IRB to ensure completeness and compliance with appropriate federal and state laws, institutional policies, and University IRB guidelines.
- Determines whether research projects are exempt from further review.
- Reviews and approves certain research projects on behalf of the IRB as a designated reviewer.
- Responsible for administrative review and management of all External IRB submission requests (commercial IRBs, NCI IRB, and other independent external IRBs).
- Corresponds with researchers, articulating required modifications to study documentation, including informed consent forms, in order to secure IRB approval, and requesting additional information needed before approval can be considered.
- Maintains active knowledge of regulations and ethical norms applicable to human subject’s research through professional development activities.
- Performs other duties as required and participate in special projects as assigned.
- Works cooperatively with other Research Compliance staff and coordinates efforts with the office, including providing coverage as needed.
- Prepares board documents for deliberation at IRB meetings, attends IRB meetings, prepares meeting minutes, and communicates IRB determinations and actions to researchers.
- Works with Research Quality and Improvement team to help develop tools, templates and guidance to support the research community.
- Works collaboratively in identifying, correcting and preventing potential problems.
- Collaborates with Executive Director and the Associate Director, Research Quality and Improvement to identify focus areas for monitoring, systems improvements, policy/procedure development/revision and education to ensure a high quality, compliant, and efficient human subject’s research program.
- Develops and participates in training and educational activities on human research protections that are presented to researchers and administrators.
- Serves as the subject matter expert by providing guidance and training to researchers, faculty, staff, students, and IRB members.
- Trains new IRB members and clinical research regulatory staff on how to use the electronic review system and facilitates onboarding.
- Works with Executive Director in the review and updates of new member orientation materials.
- Provides guidance to researchers and administrators on the use of the online electronic management systems used by the University to manage applications for review and automate correspondence.
- Works with Executive Director and team members in keeping website material up-to-date and in the development of educational resources.
- Conducts quality control functions in areas of operation to include review of files and meeting minutes for completeness, accuracy, and consistency.
- Assists the Executive Director with policy and guidance revision, procedural changes and other IRB programmatic issues.
- Assists Executive Director in the preparation of any announced federal regulatory inspections of the IRB.
- Develops and implements education sessions on topics related to human subject’s research protections to UIC researchers and IRB members.
- Anticipates future application submission for the Association for the Accreditation of Human Research Protection Program (AAHRPP) accreditation.
- Assist the Executive Director in maintaining full AAHRPP accreditation for the institutional human research protection program.
- Assists with draft AAHRPP accreditation renewal applications, annual reports, training materials for site visits, and responses to site visits.
- Regular and prompt attendance.
- Ability to work schedule as defined and additional hours as required.
- Related duties as required.
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