IRB Analyst II

## IRB Analyst IIApply:
SLU Saint Louis, MO:
Full time:
Posted Yesterday:

** Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation’s oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.
**** JOB SUMMARY
** The IRB Analyst II coordinates the daily activities associated with the processing of research protocols and all facets of protocol review management to assist the Institutional Review Board (IRB) and Human Research Protection Program (HRPP); performs audits and monitoring visits under the IRB’s Quality Assurance Review (QAR) program; assists institutional research educational activities related to human subjects protections; assists with the training of HRPP staff.

** PRIMARY JOB RESPONSIBILITIES
*** Reviews and processes exempt and expedited protocol submissions as an IRB designee; coordinates the review process of protocol submissions with IRB reviewers and, when deemed necessary, ancillary office reviewers; determines difficulty level of protocol issues and regulatory determinations; prepares protocols for IRB action; delineates revision requirements; reviews investigators’ responses; makes decisions for approval; aid reviewers’ and HRPP Director in approval decisions;

processes or administratively withdraws protocols based on established guidelines
* Facilitates the review of all central IRBs, external IRBs, and single IRB submissions; reviews HRPP policies/procedures relative to central IRBs, external IRBs, and single IRB submissions to ensure that all SLU workflows and guidelines are followed and meet current federal regulations
* Coordinates IRB meetings; prepares agenda and materials to meet distribution deadlines; reviews materials with HRPP Director and Chairs; prepares draft meeting minutes; documents IRB review determinations; monitors existing and new protocols; gathers information and background material in response to inquiries/issues raised and to make approval decisions; responds to requests for information regarding IRB review
* Assists with all quality assurance efforts, including PI quality assurance reviews (QAR) and for-cause and noncompliance audits; monitors human subject research protocols for measures of overall compliance; assists with the analysis/summary of results, identification of alternatives for resolution of issues, and development and monitoring of corrective and preventative action plans (CAPA)
* Assists with revisions and implementation of HRPP forms, policies, guidelines, and standard operating procedures; assists with development of materials required for attaining and renewing accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP); assists in the development and presentation of training and seminars to faculty, staff, and students pertaining to research issues and institutional review requirements and processes
* Serves as liaison to assigned academic units; supports researchers through the IRB process; attends workshops and conferences focused on current issues affecting the IRB oversight of the protection of human subjects in research; informs Director of issues raised by the IRB or researchers
* Assists with the training of HRPP staff, which may include Analysts I, Coordinators, or other support positions; performs internal quality assurance reviews (iQARs) of the work completed by Analysts I and II and provides constructive feedback
* Performs other duties as assigned  
** KNOWLEDGE, SKILLS, AND ABILITIES
*** Extensive knowledge of ICH/GCP guidelines, FDA regulations, OHRP regulations,…