IRB Reliance Manager

Job ID
20417
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Research Administration & Faculty Affairs

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization.  We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

 

The IRB Reliance Manager is a full-time, permanent position in the Institutional Review Office (IRO).  This position works closely with the IRB Reliance Coordinator to oversee three primary aspects of the single IRB review process – 1) negotiation of IRB reliance agreements; 2) evaluating requests from Fred Hutch investigators to rely on an external IRB; and 3) facilitating the review of participating sites that will rely on the Fred Hutch IRB. The IRB Reliance Manager must be familiar with the complex regulatory framework governing single IRB and reliance processes. This position provides expert guidance to researchers, study staff, and external organizations and IRBs regarding complex reliance scenarios.  

Responsibilities

  • Develop, implement, and manage efficient procedures to facilitate the processing of reliance agreements and single IRB (sIRB) reviews, in accordance with Fred Hutch, federal, and state policies and procedures.
  • Consult with the research teams to determine whether it is appropriate for Fred Hutch to rely on an external IRB or to serve as the sIRB.
  • Identify the need for new or revised reliance agreements and determine when Fred Hutch is engaged in research.
  • Engage IRO leadership and the Office of General Counsel, as appropriate to assist with the review of reliance agreements and associated documents.
  • Serve as the primary point of contact and expert liaison for IRB Reliance Agreements and single IRB (sIRB) review. Review complex protocols including identifying problems and issues.
  • Organize and maintain records of all reliance agreements and contact information for external IRBs and local context reviewers.
  • Review, and process external IRB submissions (where Fred Hutch relies on an external IRB), ensuring that all Fred Hutch institutional requirements for human subjects research, such as ancillary reviews, are complete.
  • Analyze submissions from external sites for completeness and compliance, using screening forms, historical records, and other resources.
  • Apply knowledge of federal, state, and local regulations, as well as institutional policies and practices, to ensure compliance with IRB Reliance Agreements.
  • Advise researchers of submission problems and suggest solutions.
  • Advise and provide input to IRB Chairs and other stakeholders regarding regulations and IRB policies.
  • Supervise the IRB Reliance Coordinator, anticipated within the first year of this role.

Qualifications

  • Bachelor’s degree with a minimum of five years of progressively responsible experience in human subjects research administration, or other field requiring familiarity with research methodologies.
  • Working knowledge of federal regulations and state laws pertaining to human subjects research.
  • Exceptional organizational skills.
  • Good analytical skills and attention to detail.
  • Strong communication (written and oral), interpersonal, and customer service skills needed to work closely and effectively with researchers and administrative personnel.
  • Demonstrated ability to work independently, exercise sound judgment and multi-task.
  • Demonstrated proficiency in the MS-Office Suite.
  • Certified IRB Professional (CIP) preferred

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment. 

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer.  We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected.  We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class.  We are an Affirmative Action employer.  We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our HR Operations at HRops@fredhutch.org or by calling 206-667-4700.

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