IRB Analyst II

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, HIPAA Privacy Rule, and HRPP policies and guidelines related to human subject protection, medical and clinical terminology, and research methodology and design Strong analytical skills with ability to identify issues and solve problems within the framework of federal and state regulations, accreditation standards and institutional requirements Excellent verbal and written communication skills Professional demeanor with ability to work both collaboratively and independently, to maintain confidentiality, and to provide excellent customer service Ability to operate personal computers, Microsoft Office products, and customized data base software Good organizational skills with ability to work on multiple projects simultaneously Flexibility and ability to adapt to a changing environment MINIMUM QUALIFICATIONS Bachelors degree Two or more years of current and relevant experience conducting, reviewing, and/or monitoring research involving human subjects Must hold CIP (Certified IRB Professional) certification PREFERRED QUALIFICATIONS Master's degree