EXAMPLES OF DUTIES:
Performs initial intake and assessment of IRB submissions for completeness prior to processing. Evaluate human research related documentation (e.g. protocols, consent forms, survey instruments etc.) for compliance with regulations, institution policy and sponsor requirements. Initiate clear and accurate written correspondence with investigators and staff, and request clarification and/or additional information to enable sound judgments to ensure compliance.
Assists with administrative pre-reviews of IRB protocols in exempt or expedited review categories, including modifications to previously approved research. Independently evaluate documentation requesting changes to protocol to evaluate whether regulatory criteria for approval will continue to be met. Evaluate research protocols in relation to federal grant proposals for congruence between the documents.
Monitor and document IRB review of projects involving human research subjects, beginning with the initial review to the projects end, applying knowledge of ethical, regulatory, legal, and institutional guidelines.
May also assist with administrative pre-review of protocols submitted for full board review.
When qualified, serves as an IRB member or alternate member and performs IRB reviews as appropriate.
Prepares detailed correspondence to investigators to communicate findings of the IRB.
Assists in the development of written policies and procedures that foster and enhance compliance in research involving human subjects.
Assists in the development of educational/training materials to facilitate compliance by investigators and key study personnel with their approved protocols, with federal regulations and relevant University and IRB policies related to the protection of human subjects participating in research.
Participates in delivering educational training programs and workshops for faculty, staff and student researchers
Serves as a resource for faculty, staff and students who have questions when preparing applications to the IRB inclusive of situations that require an Investigational New Drug application, an Investigational Device Exemption, or emergency use of a test article. Serves as a compliance resource to the research community and other interested parties. Field questions pertaining to human research subjects issues, from researchers as well as IRB committee members and others.
Attends IRB meetings, takes detailed notes and prepares minutes for review and distribution to members. Monitor and document functions of the convened IRB to ensure meetings are conducted in compliance with regulatory criteria including but not limited to advance distribution of materials to members, maintenance of quorum, committee members with a conflict are recused prior to voting, that controverted issues are brought to resolution, and that actions taken by the board, are documented and presented to institutional officials.
Maintains IRB study-related documents and digital records in accordance with federal guidelines, IRB and institutional policies and procedures.
Maintains professional and technical knowledge including but not limited to State and Federal regulations related to human subject research, Good Clinical Practice Guidelines, ethical principles governing human subject research and relevant institutional policies by attending educational sessions and reviewing documents published by Federal or State agencies. Ensures that changes in such are communicated to the appropriate person(s).
Review material for which affirmation is sought that the activity is not human subject research and independently make determinations.
Collaborate with external IRB administrators to facilitate execution of IRB Reliance Agreements such that research protocols that involve multi-site participation are implemented in compliance with regulatory standards for IRB review.
May subsequently conduct, or assist with conducting, audits of the implementation of the approved protocol or exempted activity to ensure implementation practice is consistent with documentation.
May observe the informed consent process and/or conduct of the research to evaluate compliance with regulations related to human subject protections and/or the directives of the IRB.
Monitor study status to ensure appropriate approval has been maintained, providing direction for how to secure it if necessary; and monitor study progress as protocols are submitted for continuing approval, alerting IRB to any noted concerns.
Review submission of Problem Report Forms, which may encompass adverse event reports, to ensure appropriate actions are taken and appropriate personnel are notified within required time frames.
Monitor complaints from participants in clinical research trials, ensuring all information is gathered, appropriate action is taken to bring protocol into compliance if necessary, and that appropriate parties are informed.
Act as liaison with other committees related to research compliance such as with other institutional review board panels (internal or external to UConn Health), financial conflict of interest committee, institutional biosafety committee, stem cell oversight committee.
Monitor compliance with conflict-of-interest management plans as related to human subject research activities, and as necessary provide guidance to faculty as to how to bring proposal into compliance with management plans by requiring corrective actions such as disclosures in consent forms.
Develop and remit correspondence directly to Federal Agencies and institutional officials (e.g., Prisoner Certification Letters, reporting of unanticipated problems, non-compliance, suspension or termination of IRB approval). Interact directly with Federal authorities and/or representatives from accrediting agency when on site for inspection/accreditation visits.
Obtains Certified IRB Professional (CIP) certification when eligible and/or maintains CIP certification.
Performs other duties as required.