Job Description

IRB Operations Manager

Job ID 15185 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.

This position manages day-to-day operations of the IRB staff to ensure that IRB staff provides the best possible support to IRB Committees and excellent service to investigators and research staff.

Responsibilities

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 (IRO) with Assistant Director

Consistent, timely, thorough preparation of IRB materials

• Check in with staff and monitor workloads daily
• Redistribute workloads as needed
• Monitor to ensure follow-up is executed
• Attend all IRB meetings
• Pre-review IRB meeting agendas
• Review result letters and minutes
• Conduct regular meetings with Analysts to address issues of policy, procedures and consistency
• Maintain and update IRB Committee member records, Board rosters, and FWA
• Oversee IRB member continuing education, annual member evaluations, member conflict of interest tracking, and appointment/reappointment process

Well developed, high trust, high performance work team

• Perform hiring and termination of IRB staff
• Oversee training of new 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
• Support staff in defining and moving toward their goals for career growth

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

Collaborative management of IRO with Director, Assistant Director, and Admin Coordinator

• Meet regularly with Assistant Director and Admin Coordinator
• Collaboratively manage IRB workflow with the Admin Coordinator
• 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 on other delegated projects (e.g., AAHRPP Human Subjects Training, etc.)
• Attend regular IRO Management meetings

Qualifications

• Bachelor’s degree (advanced degree preferred)
• 3-5 years Institutional Review/Human Subjects experience OR Fred Hutch experience in support to research projects/grants; or equivalent combination of education and experience
• 3+ years in a supervisory role
• 1-3 years' experience in IRB personnel management
• IRB training as appropriate
• Ability to manage and develop professional staff
• Effective interpersonal/negotiation skills
• Effective written and verbal communication skills
• Proficient with IT tools including databases
• Proficient in word processing and previous experience with MS office programs (MS word, Access, Excel) required
• Working knowledge of federal regulations applying to IRBs, including 21 CFR 50 and 56, and 45 CFR 46
• Ability to lift 25 pounds
• CIP certification preferred

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 Employee Services Center at [email protected] or by calling 206-667-4700.

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