IRB Administrator I

About Children’s Minnesota

• Children’s Minnesota is one of the largest pediatric health systems in the United States and the only health system in Minnesota to provide care exclusively to children, from before birth through young adulthood.
• An independent and not-for-profit system since 1924, Children’s Minnesota is one system serving kids throughout the Upper Midwest at two free-standing hospitals, nine primary care clinics, multiple specialty clinics and seven rehabilitation sites.
• As The Kids Experts™ in our region, Children’s Minnesota is regularly ranked by U.S.
• News & World Report as a top children’s hospital.
• Find us on Facebook @childrensminnesota or on Twitter and Instagram @childrensmn.
• Please visit childrensMN.org.

Children’s Minnesota is proud to be recognized by Modern Healthcare as one of 2023’s Top Diversity Leaders. The national honor recognizes the top diverse healthcare executives and organizations influencing public policy, care delivery, and promoting diversity, equity and inclusion in their organizations and the industry.

Department Overview

• Proudly serving as Minnesota's children's hospital since 1924, Children's Hospitals and Clinics of Minnesota, is the eighth-largest pediatric health care organization in the U.S.
• Each year, Children's provides care through nearly 13,000 inpatient visits and more than 200,000 emergency room and other outpatient visits.
• An independent, not-for-profit health care provider, Children's has 319 staffed hospital beds and services available in all major pediatric specialties: emergency care; newborn and pediatric intensive care; outpatient and inpatient surgery; diagnostic services, including radiology and laboratory; and special programs in the areas of respiratory, cardiology, cancer, premature birth, adolescent development, child abuse, and epilepsy.
• In addition to our Minneapolis and St.
• Paul Campuses, Children's also includes Children's West, a pediatric care center in Minnetonka offering same-day surgery as well as diagnostic, rehabilitative, and developmental outpatient services; Children's - Roseville, an outpatient pediatric rehabilitation center; and Children's Clinics - Woodwinds, pediatric specialty clinics at the Woodwinds Health Campus in Woodbury.

Position Summary

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.

Location (e.g. remote or on-site): Remote (MN or WI)

License/Certification/Registration required? No

Education: *Bachelor's degree in a related field required *Certified IRB Professional certification preferred

Experience

*3+ years of direct IRB administration experience required *IRB administration in healthcare or hospital environment required *Experience in a pediatric environment preferred

Knowledge/Skills/Abilities

*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) *Knowledge of iMedRIS, preferred

Physical Demands: Please click here to view the Physical Demands

The posted salary represents a market competitive range based on salary survey benchmark data for similar roles in the local or national market. Annual salaries displayed are based on full-time employment (40 standard hrs per week). Annual salaries for part-time positions will be prorated based on the employee’s scheduled weekly hours in relation to the full-time standard. When determining individual pay rates, we carefully consider a wide range of factors including but not limited to market indicators for the specific role, the skills, education, training, credentials and experience of the candidate, internal equity and organizational needs.

In addition to your salary, this position may be eligible for medical, dental, vision, retirement, and other fringe benefits. Positions that require night, weekend or on-call work may be eligible for shift differentials or premium pay.

All job offers are contingent upon successful completion of an occupational health assessment, drug screen, background investigation, and compliance with the U.S. Government Form I-9, Employment Eligibility Verification.

Children’s Minnesota is proud to be an equal opportunity employer whose staff is representative of its community and considers qualified applicants for open positions without regard to race, color, creed, sex, religion, national origin, sexual orientation, genetic information, gender identity or expression, age, veteran status, disability, pregnancy, citizenship status, or any other characteristic protected under applicable federal, state, or local law.