Institutional Review Board (IRB) Administrator

Concordia University Wisconsin/Ann Arbor•Mequon, WI

1d•Remote

About The Position

Concordia University is a Lutheran higher education community committed to helping students develop in mind, body and spirit for service to Christ in the Church and in the world. Position Summary The IRB Administrator serves as CUWAA's Institutional Review Board (IRB) primary contact. The role will be positioned within the Office of Research and Sponsored Programs and can be based at our Mequon, WI campus or our Ann Arbor, MI campus. Remote employees will also be considered.

Requirements

Strong familiarity with 45 CFR 46 (Common Rule).
Excellent communication and customer service for advising faculty/students
Strong organization, attention to detail, and recordkeeping
Discretion with confidential/sensitive information; sound judgment
Training/outreach capability for faculty and student investigators
Supportive of the mission and values of Concordia University Wisconsin/Ann Arbor and the Lutheran Church Missouri Synod (LCMS)
Bachelor's degree required
3-5 years of demonstrated experience with IRB processes.

Nice To Haves

Advanced degree (master's or higher) preferred.
Experience administering or using Cayuse IRB strongly preferred.

Responsibilities

Ensure compliance with 45 CFR 46, OHRP guidance, and CUWAA policies.
Conduct administrative pre-reviews; determine review category (Exempt, Expedited, Full Board); flag when Limited IRB Review applies.
Coordinate meetings; manage agendas, quorum, reviewer assignments; prepare compliant minutes; maintain IRB roster and member training records (CITI).
Maintain approvals, determinations, deferrals, correspondence, and adverse event/unanticipated problem reports in accordance with retention requirements.
Advise on applications; consent/assent/waiver language; recruitment materials; data security/FERPA/HIPAA considerations; specimen/data use.
Administer and verify CITI/RCR completion; maintain centralized training logs linked to protocol personnel.
Administer the eIRB system (Cayuse) including workflows, forms, templates, permissions, user support, and quality control.
Conduct routine and for-cause monitoring; coordinate responses to noncompliance or reportable events.
Assist with updates to IRB SOPs and related research integrity policies to align with current federal standards.
Organize and deliver professional development to faculty and students.
Collaborate closely with the IRB Chair and members, ORSP pre- and post-award staff, Finance, Legal/Compliance, IT/Data Security, and academic units.