IRB Manager, Minimal Risk Research, Office of Research ...

Conduct non-committee IRB reviewsConduct in-depth reviews on assigned IRB submissions to ensure submissions are adequately prepared and meet all regulatory criteria for approval or exemption from federal regulations or not human subjects research (NSHR) criteria.Identify regulatory issues requiring correction prior to approval and correspond in a clear and concise manner with investigators, coordinators, and/or other appropriate study personnel to resolve identified issues.Work collaboratively with colleagues and researchers to ensure all reviews are completed accurately and in a timely manner.Serves as an alternate voting member on the IRB committee and is designated to independently conduct expedited IRB reviews of research involving human terprets and successfully applies federal regulations, state law, accreditation standards, and institutional policy to research submissions at all stages of IRB review.Identifies issues or concerns that must be addressed in order to approve the research.Attends and participates in committee meetings, as needed.Acts as Privacy Board member to assess applicability and provide determination regarding requests for HIPAA authorization waivers.Works with other IRB Managers to coordinate activities as needed.Directly Supervise IRB Analyst(s) and Sr. Analyst(s) on Assigned TeamManages a team of IRB Analysts and oversees the activities that support non-committee review of IRB submissions.Manages team workload, monitors team productivity and ensures appropriate turnaround time and sufficient level of review and appropriate determinations.Works collaboratively with other IRB Managers to triage and assign submissions to IRB Analysts, making an initial determination regarding necessary level of review.Evaluates staff performance to include assessing quality, productivity, and efficiency and provides ongoing feedback to staff and HRPP leadership, as appropriate.Holds regularly scheduled staff meetings.Hires, trains, supervises, and oversees assigned IRB staff in the daily operations of the minimal risk research review team in the IRB office.Facilitates professional development of direct reportsManage Non-Committee Review Program Operations and Supports the Human Research Protection ProgramProvides backup to the IRB staff with regard to IRB submission review when needed and as submission volume requires.Identifies and addresses workflow issues as they arise so that quality and efficiency are optimally maintained.Works collaboratively with IRB leadership to develop, implement, and revise Standard Operating Procedures (SOPs) to enhance efficiency and effectiveness of non-committee operations including procedures for investigators and SOPs for administrative function of the IRB.Ensures compliance with policies and procedures and informs IRB team members of changes in policy and procedure in a timely fashion.Provides feedback and suggestions to the HRPP leadership regarding the operations and needs of minimal risk research review team.Utilizes IRB metrics to provide insight into opportunities for quality and process improvement; prepares and submit regular reports related to IRB and HRPP activities to leadership.Serves as a resource to IRB and HRPP leadership for consultation regarding day-to-day IRB operations of Minimal Risk Research Team.Works with IRB and HRPP leadership to develop procedures, work instructions, tools, templates, applications, and guidance to support IRB staff and the research community with respect to the IRB submission, review, and approval process.Together with other IRB and HRPP leadership, maintains relationships with departmental research leadership and ancillary review departments to assess their needs and facilitate ongoing communication to support the submission, review, approval, and conduct of research with human subjects.Demonstrates clear, high-level knowledge, practice, and application of HHS regulations, FDA regulations and guidance, HIPAA Privacy Rule, and ins itutional policies related to human subject protection and clinical research to ensure compliance.Maintains current knowledge of evolving guidance and regulations.Attend meetings, conferences and seminars on work-related topics.Volunteer for and performs other job-related duties as needed and/or assigned.Provides Support to Research CommunityServes as subject matter expert in state and federal laws and regulations as they apply to human subjects research and provides quality customer service and regulatory support to all constituents.Serves as front line researcher support representative at least 1 day/week (rotating responsibilities with other IRB Managers/Sr. Staff as designated by IRB leadership).Acts as a role model for other professionals by communicating responsively, respectfully, and positively.Reinforces clear expectations for customer service and vestigates and answers regulatory questions from research community, including phone calls, emails, and in-person requests.Manages issue and complaint resolution related to IRB submission and non-committee review processes.Collaborates with other IRB Managers to supervise customer service initiatives provided by IRB Analyst staff (e.g., IRB Chat, helpline, email).

Created: 2026-03-07