IRB Operations Mgr

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

Fred Hutchinson Cancer Research Center, home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the Center's five scientific divisions collaborate to form a unique environment for conducting basic and applied science. The Hutchinson Center, in collaboration with its clinical and research partners, the University of Washington and Seattle Children's, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. Join us and make a difference!

Fred Hutch is accredited through the Association for the Accreditation of Human Research Protections (AAHRPP). The Institutional Review Office coordinates the activities of four IRBs and manages 1600 protocols. Studies reviewed include biomedical and prevention trials, epidemiologic studies, genomic studies, as well as social and behavioral research. Fred Hutch has developed collaborative IRB arrangements with more than 100 assured organizations or registered IRBs. We are looking for the right candidate to manage the day to day operations of our busy IRB system, lead our IRB team, and ensure the Fred Hutch IRB system continues to provide the best possible support to our IRB members, our researchers, and most importantly our research participants.

Critical Results:
- Consistent, timely, thorough preparation of IRB materials and documentation
- Well developed, high trust, high performance work team
- Quality customer service and consultancy to all constituents
- Collaborative management of the Institutional Review Office with the Assistant Director

1. Ensure IRB team is delivering consistent, timely, thorough preparation of IRB materials
- Manage daily workflow and work assignment
- Redistribute workloads as needed
- Attend all IRB meetings
- Review IRB agendas, result letters, minutes
- Conduct regular meetings with Analysts and Administrative Coordinator
- Manage issues of policy, procedures and consistency with the IRB team
- Maintain and update IRB Records with OHRP (i.e. rosters and Federal Wide Assurance [FWA])
- Maintain IRB Member training, records, CVs, evaluations

2. Well developed, high trust, high performance work team
- Oversee hiring and training of IRB staff
- Conduct regular supervisory meetings with individual staff members
- Provide regular feedback to staff and solicit feedback frequently
- Model positive, direct communication and conflict resolution
- Address performance issues swiftly and confidentially

3. Quality customer service and consultancy to all constituents
- Establish clear expectations for customer service and consultancy
- Solicit feedback from constituents
- Provide guidance to staff in complex cases
- Assist staff in resolving complaints

4. Collaborative management of IRO with Assistant Director
- Collaboratively manage work flow between all parts of IRO
- Inform IRB team members of changes in policy and procedures
- Co-lead IRO staff meetings with Assistant Director
- Serve as back-up to Assistant Director (e.g., AAHRPP accreditation, Human Subjects Training)

Qualification Minimum:
- Bachelor's degree; and either six years Institutional Review/Human Subjects experience OR eight years FHCRC experience in administrative support to research projects/grants; or equivalent combination of education and experience.
- Minimum 2 years prior supervisory or management experience required.
- Knowledge of FDA 21 CFR 50, 56 and HHS 45 CFR 46 regulations required.
- Must demonstrate organizational and communication skills.
- Attention to detail required.
- Proficient in word processing and experience with MS office programs (MS word, Access, Excel) required.
- Ability to lift 25 pounds
- Must be able to read physical documents.

Preferred:
- Demonstrated progressively responsible management experience in human subject protection field.
- Specific experience as an IRB operations manager
- Certified IRB Professional (CIP)
- Experience working with, or implementing, electronic IRB submission systems
- Experience with process improvement methodologies and techniques

We are a VEVRRA Federal Contractor.

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2227792-2647-3521

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