IRB Reviewer Specialist, Division of Research & Innovation
Wayne State University is searching for an experiencedIRB Reviewer Specialist, Division of Research & Innovationat its Detroit campus location.
Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan where students from all backgrounds are offered a rich, high-quality education. Our deep-rooted commitment to excellence, collaboration, integrity, diversity and inclusion creates exceptional educational opportunities which prepare students for success in a global society.
Position Purpose:
The Institutional Review Board Administration Office is responsible for ensuring that 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 Institutional Review Board Reviewer Specialist will be responsible for providing senior level analysis and review of minimal risk research submissions (i.e. Exempt and Expedited research), serve as the pre-reviewer full board submissions determining if full board review is appropriate and address approval criteria prior to full board review, provide guidance to Institutional Review Board administrators and Institutional Review Board reviewers/members, review administrative applications and just-in-time federal award submissions. The IRB Reviewer Specialist role is vital component of facilitating efficient and timely reviews of assigned submissions for minimal risk human participant research activities to be conducted at WSU and WSU affiliate locations.
Essential Functions:
Serve as experienced senior reviewer for Institutional Review Board submissions as per federal regulatory requirements and institutional policies and procedures related to the approval and conduct of human participant research. Serve as a member of designated Institutional Review Board review committee(s). Analyze and determine research submissions meet appropriate regulatory criteria. Approve and/or determine required revisions to meet regulatory and institutional requirements for the conduct of human participant research. Review investigators' responses for concurrence with criteria of human participant research requirements.
Provide direction concerning approval determinations to Institutional Review Board administrators/staff regarding the processing of Institutional Review Board approvals. Communicate revisions requirements to designated Institutional Review Board administrators/staff and/or investigators/submitters.
Pre-review full board submissions for regulatory requirements, process Administrative Application and/or just in time submissions.
Provide recommendations to Institutional Review Board/Human Research Protection Program leadership to improve efficiency of reviews and turnaround times. Make recommendations regarding investigator/submitter education.
Other duties as assigned.
Minimum Qualifications:
Education: Master's degree
Master's degree required. Graduate degree from an accredited college or university in relevant fields such as law, ethics, public health or basic sciences, social sciences or equivalent experience in the field of research compliance or research regulatory support.
Experience: Intermediate (3 to 4 years job-related experience).
Minimum of 3-4 years' experience with Institutional Review Boards, ethics board procedures, and research submission methods and procedures required.
3-4 years' experience in IRB, research field, or similar required.
Knowledge of social behavioral, education, psychological, pharmaceutical, medical and/or drug agency research.
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.
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.
Preferred qualifications:
Certified IRB Professional (CIP) certification preferred.
School/College/Division:
Division of Research & Innovation
Primary department:
H0955 - Human & Animal Research Compliance
Employment @type:
Regular Employee
Job @type: Full Time
Job category: Staff/Administrative
Funding/salary information:
Compensation @type: Annual Salary
Annual Salary: 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.
