The Institutional Review Board (IRB) Analyst assists the Human Research Protections (HRP) Director and IRB Supervisor in facilitating the HRP program in accordance with federal and state requirements, MHS policies and procedures and accreditation standards. The specific responsibilities of this position include the management of the IRB application processes, assisting researchers and research team members in completing IRB forms and templates, communicating the determination of IRB review, compliance with IRB policies and procedures, contributions to and participation in IRB initiatives, process improvement and Research Administration optimization goals. This position will also serve as a liaison for studies under external IRB oversight, which may include: NCI CIRB, Commercial Central IRBs and other IRBs.
Essential Functions and Responsibilities of the Job
Ensure compliance with all applicable Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) and state regulations and requirements, as well as MHS policies and procedures for research at all MHS campuses
Maintain good working knowledge of MHS policies and procedures and federal and state regulations on human subjects research.
Serve as a liaison and information resource to MHS researchers and research staff, IRB members and other committees as appropriate by advising them on all federal and state requirements and MHS policies for approval of research.
Conduct pre-reviews of all research submissions prior to IRB/Chair/Expedited review to ensure all requisite documents are provided.
Serve as a liaison for studies under external IRB oversight and perform administrative review of documents to ensure completeness and compliance with appropriate regulations and policies.
Interact with investigators and research teams to ensure appropriate and complete study submissions.
Prepare required documentation, materials communications for completeness and consistency for IRB members and any sub-committee proceedings.
Develop, organize, maintain documentation involving the IRB Membership Handbook, IRB minutes for fully convened IRB meetings, IRB expedited review documentation, Privacy Board Membership Handbook and Privacy Board documentation.
Work with IRB members to develop meeting schedule, arrange meeting rooms, prioritize protocols to assign to meetings, maintain an awareness of members’ conflicts of interest prior to assigning protocols to reviewers and during the review process, ensure quorum is planned, provide all necessary materials for meetings and provide expert advice during meetings on federal and state regulations and MHS policies.
Enhance quality and integrity of IRB review through required utilization of various systems, processes, and programs established for the IRB administration function.
Increase transparency of IRB and IRB administration operations through heightened communications with customers, colleagues, and research subjects.
Serve as a primary IRB administration point of contact for individual, group, department, and/or specialty research entities as assigned.