IRB Administrator I

Children’s Minnesota • Minneapolis, MN

34d • Remote

About The Position

The Institutional Review Board (IRB) Administrator I, under general supervision, administers protocol activities, such as submissions, reports, renewals, and revisions. This position provides support to all aspects of workflow and support for the IRB. This role requires a regulatory professional with experience capable of performing highly technical reviews of research protocols, ensuring compliance with Federal Regulations (45 CFR 46, 21 CFR 50, 56), and serving as a primary liaison between the IRB and the research community.

The IRB Administrator I must be comfortable collaborating with senior leadership, faculty, staff, students, medical professionals and external agencies in communicating federal and organization requirements to stakeholders. In addition, position will be assisting in program and policy development in response to government agency updates and handling multiple projects with competing deadlines.

Requirements

• Bachelor's degree in a related field required
• 3+ years of direct IRB administration experience required
• IRB administration in healthcare or hospital environment required
• Working knowledge of IRB (Institutional Review Board) Administration and applicable federal and state regulations, policies and procedures for human subjects' research; including FDA and OHRP regulations and guidelines, specifically with pediatric populations/Subpart D
• Strong written, verbal and interpersonal communication skills
• Organizational skills
• Ability to manage and prioritize multiple priorities
• Proven ability to interpret Federal and State regulations particularly, regarding the protection of human subjects in biomedical research
• Experience with IRB management of electronic software for IRB submissions
• Knowledge of Microsoft suite (Word; Excel; PowerPoint; Outlook; Teams)

Nice To Haves

• Certified IRB Professional certification preferred
• Experience in a pediatric environment preferred
• Knowledge of iMedRIS, preferred

Responsibilities

• Administers protocol activities, such as submissions, reports, renewals, and revisions
• Provides support to all aspects of workflow and support for the IRB
• Performs highly technical reviews of research protocols
• Ensuring compliance with Federal Regulations (45 CFR 46, 21 CFR 50, 56)
• Serving as a primary liaison between the IRB and the research community
• Collaborating with senior leadership, faculty, staff, students, medical professionals and external agencies in communicating federal and organization requirements to stakeholders
• Assisting in program and policy development in response to government agency updates
• Handling multiple projects with competing deadlines

What This Job Offers

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