IRB Analyst

Saint Louis University • St. Louis, MO

1d

About The Position

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: Under administrative direction, 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); assists with audits and monitoring visits under the IRB’s Quality Assurance Review (QAR) program.

Requirements

• 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 database software
• Good organizational skills with ability to work on multiple projects simultaneously
• Flexibility and ability to adapt to a changing environment
• Bachelor’s degree; with two (2) years of human subjects research related experience.

Responsibilities

• Reviews and processes human subjects research determination requests and exempt research applications to ensure they meet the regulatory requirements and adhere to applicable local laws and institutional policies; assists researchers throughout the IRB submission process; corresponds with researchers on necessary revisions, if applicable.
• Reviews and processes protocol submissions; 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; assists in preparing 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.
• 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 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 Coordinators or other support positions.
• Performs other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level