IRB Analyst or Senior IRB Analyst, Office of Research ...

IRB Analyst:IRB Submission Analysis and Review (Committee and Non-Committee Review)Analyze research applications, utilizing independent judgment, to conduct in-depth review to ensure IRB submissions are adequately prepared and meet all regulatory criteria for approval or exemption from federal regulations.Identify regulatory, policy and ethics issues requiring correction prior to approval. Correspond with investigators, coordinators, and/or other appropriate study personnel to resolve identified issues.Work collaboratively with colleagues, ancillary reviewers, and researchers to ensure all reviews are completed accurately and in a timely manner.Identify and promptly communicate any issues with research review process, study documentation and determinations, to leadership to maintain high quality and accurate records.Maintain working knowledge of current federal and state regulations, guidelines and trends influencing the conduct of human subjects research and research/medical ethics and applies knowledge to IRB reviews.Maintain current knowledge of UT IRB policies and procedures and any updates or additions that may be mittee Review Team:Provide consultation to IRB members regarding meeting conduct requirements, institutional policies and procedures, and state/federal regulations.Work collaboratively with IRB member(s) to review submissions in a timely manner and provide feedback to researchers within established timelines.Attend and participate in monthly convened IRB plete post-meeting activities to ensure discussion and determinations are appropriately documented.Supports the HRPP and Serves as a Resource for Research CommunityProvide consultation and education to investigators and research staff regarding regulatory requirements and IRB written policies and procedures.Provide support to the research community through IRB Chat, Virtual Office Hours, and other initiatives, as needed.Works collaboratively with colleagues to create and revise standard operating procedures and guidance documents pertinent to the IRB review process and full board operations under the guidance of IRB leadership, as appropriate.Engage with leadership in identifying areas of improvement and assist in developing solutions and implementation of changes.Identify and promptly communicate any issues with internal or external facing resources to leadership to maintain high quality and accurate information for our department and larger research community.Attend and contribute to ORSC, IRB and team specific meetings and trainings to ensure thorough knowledge of changes, updates and initiatives.Assists in the training and the continuing education of colleagues and new employees.Participate in departmental and external educational activities contributing to professional development.Performs other job-related duties as needed and/or assigned.Senior IRB Analyst:IRB Submission Analysis and Review (Committee and Non-Committee Review)Serve as a member of the UT Institutional Review Board (IRB). Serves as a designated reviewer with the authority to make independent regulatory determinations, provide exempt determinations, approve expedited research, and approve changes to full board research that are eligible for expedited review. Serves as Privacy Board dependently review biomedical and behavioral research proposals submitted to the IRB in compliance with Federal, state, local regulations/laws and Institutional policies and procedures. Identifies issues or concerns that must be addressed in order to approve the research and communicates issues to researchers in a professional and educational manner.Ensure accurate and timely processing, tracking, and review of submissions and documentation of IRB determinations.Guide investigators through the application submission process. Independently advises investigators on applicable policies, procedures, guidelines, federal regulations, and other compliance related requirements.Review requests to amend or modify approved protocols and make determination about which requests require full IRB review and which can be reviewed using an expedited process (committee review team).Manage the intake and review process of reportable new information for assigned protocols, which may include unanticipated problems, non-compliance or allegations of non-compliance with federal, state, or institutional regulation, policy, or guidance, and safety reports. Present reportable information to IRB Chair and committee members, as required.Ensure timely processing, review and disposition of research applications within established expectations and SOPs.Work collaboratively with leadership and the electronic submission team to resolve problems, suggest improvements and test programming mittee review team: Provide expert support to IRB members regarding meeting conduct requirements, institutional policies and procedures, and state/federal regulations and function as a liaison within and between the IRB committee, investigators, and other staff.Assist committee manager with preparing meeting agendas and assignment of reviewers for each panel meeting based on knowledge of scientific aspects of the research submissions to be reviewed, as well as regulatory requirements and the expertise/role of each panel member.Participate in administrative functions of IRB meetings, including ensuring quorum, providing regulatory guidance at the meeting and ensuring meeting minutes are complete, accurate, and provided to members per established SOPs.Participate in training new IRB committee members and ongoing education of current committee members.Actively participate in monthly convened IRB meetings. Act as an alternate voting member when needed.Supports the HRPP and Serves as a Resource for Research CommunityServe as subject matter expert in state, local, and federal laws and regulations as they apply to human subjects. Demonstrate a clear, high-level knowledge of institutional policies and procedures and best practices related to human subjects protection.Serve as a point of contact for questions and concerns from IRB Analysts, IRB members, research teams, and other stakeholders.Participate in various customer service activities including IRB Chat, Virtual Office Hours, and other initiatives, as needed.Participate in the development and implementation of standard operating procedures (SOPs) and other guidance documents pertinent to the IRB review process and committee/non-committee IRB operations.Work collaboratively with leadership and the electronic submission team to resolve problems, suggest improvements and test programming upgrades.Maintain working knowledge of best practices and trends within the human research protection field.Volunteer for and perform other job-related duties as needed and/or assigned.Provide Mentorship/Guidance to IRB Analyst StaffProvide guidance and mentorship regarding regulatory, policy, or process questions and assist with workflow and workload issues.Provide feedback to IRB Analysts regarding their pre-reviews of IRB submissions to ensure regulatory compliance and facilitate better understanding.Assist in training new IRB Analysts and provide on-going guidance regarding application of federal, state, and institutional regulations, guidance, and policies to human subjects research.Creates educational presentations, materials, and guidance to aide in IRB staff understanding of relevant topics.Foster a collaborative team environment and keep management apprised of issues/needs of the staff.

Created: 2025-11-15