Institutional Review Board (IRB) Regulatory Analyst, Part-Time

exceptional educational opportunities which prepare students for success in a global society. Position Purpose: The Institutional Review Board (IRB) Administration Office is responsible for ensuring Wayne State University (WSU) and WSU affiliate human participant research activities comply with all applicable laws, regulations, and policies, including standards of excellence necessary for maintaining accreditation status. The IRB Regulatory Analyst is responsible for providing expert analysis and conducting reviews of minimal-risk research submissions, including expedited amendments, expedited continuing reviews, and minimal risk initial submissions to ensure compliance with federal regulations, institutional policies, and ethical standards for the protection of research participants. This position evaluates submission materials for completeness, accuracy, and regulatory appropriateness; communicates with IRB Administration Office support staff, investigators, and study teams to resolve review issues; and helps facilitate timely, consistent, and well-documented determinations. This position reports to the Director, Human Research Protection Program (HRPP). Essential Functions : Conduct expert regulatory and institutional review and analysis of minimal-risk research submissions, including initial minimal risk submissions, expedited amendments, and expedited continuing reviews. Evaluate IRB submission materials for completeness, accuracy, consistency, and regulatory appropriateness; identify needed revisions or clarifications. Communicate with IRB Administration staff, investigators, and study teams to resolve review issues and provide guidance regarding IRB requirements. Prepare and maintain accurate review of documentation, determinations, correspondence, and records to support timely and consistent IRB decisions. Support compliance with federal regulations, institutional policies, ethical standards, and accreditation requirements through consistent application of IRB procedures. Maintain current knowledge of human participant protection requirements. Perform other duties as assigned. Minimum Qualifications: Education : Master’s degree Master’s degree from an accredited college or university in health, bioethics, health sciences, social sciences, regulatory affairs, research administration, public administration, or related field preferred. Experience : Intermediate (3 to 4 years’ job-related experience). Experience conducting, supporting, or reviewing research involving human participants. Experience in evaluating IRB submissions, understanding research design, and assessing participant protections. Knowledge, Skills, and Abilities : Knowledge of U. S. Food and Drug Administration (FDA), U.S. Department of Health and Human Services Office of Human Research Protections (OHRP), U.S. Department of Defense (DoD), etc. regulations and guidelines; Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards; and institutional policies. Understanding of complex regulatory requirements and institutional policies regarding the approval of human participant research. In depth knowledge of federal, state, and local regulations regarding the protection of humans in research. Ability to negotiate/mediate with a variety of professionals including scientists and physician investigators, and a diverse research community. Strong understanding of all the technical terminology involved in the work to decide which research projects and protocols need to be discussed. Appointment to applicable institutional review board/committees at time of hire. Knowledge and experience with university policies, procedures, and practices surrounding the approval of research. Advanced written, oral, and interpersonal communication skills. Strong prioritization, organizational, and analytical skills. Strong customer service skills and ability to work independently in a deadline-driven environment. Ability to establish and meet deadlines, work under extreme pressure, and function independently. Excellent customer service and communication skills to work effectively with faculty, staff, students, and research representatives from a variety of diverse backgrounds are required and are essential to succeed in this position. Attention to detail and ability to continuously multi-task in a fast-paced work environment is essential to succeed in this position. School/College/Division: The Division of Research & Innovation Primary Department: H0955 - Human & Animal Research Compliance Employment Type: Regular Employee Job type: Fractional Time Job category: Staff/Administrative Funding/Salary Information: Compensation type: Hourly Wage Hourly Rate: To be determined Working Conditions: Normal office environment. Job Openings: Number of openings: 1 Reposted position: No Background check requirements: University policy requires certain persons who are offered employment to undergo a background check, including a criminal history check, before starting work. If you are offered employment, the university will inform you if a background check is required.