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Institutional Review Board (IRB) Training Coordinator, Division of Research

Wayne State University is searching for an experiencedInstitutional Review Board (IRB) Training Coordinator, Division of Researchat 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 (IRB) Training Coordinator is the primary educator and informational resource for the research community, Institutional Review Board members, faculty, and staff responsible for various educational activities related to the Wayne State University (WSU) Institutional Review Board.

Essential Functions:

Monitor changing regulatory landscape, assisting in writing IRB policies and procedures to remain current with regulatory requirements and guidance. Responsible for assuring that all educational materials, tools, and resources are in strict compliance with federal and state regulations and Institutional policies governing human research and are reflected in the policies and forms. Develop and maintain educational materials, documents, resources and tools for the research community, IRB members, and IRB staff to aid in understanding all interactions with the IRB and regulatory bodies.

In collaboration with the Associate Director, Director, IRB Administration Operations management, maintain IRB policies and procedures and IRB forms. Assist with preparing for audits by federal regulatory agencies, regulatory bodies, and accreditation bodies (Food and Drug Administration, Office for Human Research Protection, AAHRPP, VA, etc.).

Association for Accreditation of Human Research Protection Programs: AAHRPP Re-Accreditation work begins every 4-5 years which shifts this % time during that period making this function category more like 30% and shifting the first 2 categories listed down to 10% where education activities are focused refreshers on AAHRP standards.

Develop and maintain a comprehensive education program for the protection of human participants in research. Convey investigator responsibilities of IRB and regulatory reporting to the research community to maintain and promote compliance at WSU.

Develop, maintain, and deliver IRB trainings on a variety of topics at a variety of locations and times, associated with IRB submissions, review, and approval of human research protocols. Develop and deliver individual sessions for faculty, affiliates, staff, and students who wish to conduct human participant research. Coordinate with various academic units to develop and conduct training programs unique to their fields.

Process Human Participant Research Determinations and Administrative Application. Assist with Single Time Use Processing and Submission Pre-reviews.

Conduct investigator training as directed by the Institutional Review Board (IRB). Develop, coordinate, and deliver trainings and educational materials for IRB members, prospective IRB members and IRB staff as directed.

Other duties as assigned.

Minimum Qualifications:

Education: Bachelor’s degree

Bachelor’s degree from an accredited college or university or equivalent experience in the field of research compliance or research regulatory support.

Experience: Experience (minimum 2 years of job-related experience)

Minimum of 2 to 5 years’ experience with Institutional Review Boards, ethics board procedures, and research submission methods and procedures. 3 years’ experience in IRB, research field, or similar.

Some knowledge of psychological, pharmaceutical, medical and/or drug agency research.

1 to 3 years’ experience teaching preferred.

CIP certification is preferred.

Knowledge, Skills, and Abilities:

Advanced written, oral, and interpersonal communication skills.

Strong prioritization, organizational, and analytical skills.

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 customer service skills and ability to work independently in a deadline-driven environment.

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.

Knowledge of and ability to proficiently use a PC and computer-based applications.

Attention to detail and ability to continuously multi-task in a fast-paced work environment is essential to succeed in this position.

Ability to establish and meet deadlines, work under extreme pressure and function independently.

Ability to work occasional evenings and early mornings, as needed by research community for presentations, etc.

School/College/Division:

H09 - Research

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

Some evening and weekend work is required

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.

Equal employment opportunity statement:

Wayne State University provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. The university encourages applications from women, people of color and other underrepresented people. Wayne State is an affirmative action/equal opportunity employer.