Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Institutional Review Board (IRB) reviews research activities involving human subjects to uphold ethical standards and to ensure research activities comply with all pertinent regulations and Fred Hutch policies. The Institutional Review Office (IRO) staff are key players in supporting the IRB to carry out this mission.

This full-time, permanent position reports to the IRO Coordinator Supervisor and is responsible for mission-critical work in three main areas:

• Verifying that human subjects research and animal welfare research approvals are in place using the Funding Verification and Activation Form (FVAF), so the institution can release funding to investigators.
• Providing administrative and tracking support for the IRB Human Subjects Protection (HSP) and Good Clinical Practice (GCP) training program to ensure training compliance is maintained.
• Primary contact for departmental email and main phone line, responding to questions independently and escalating to appropriate individuals when needed.

Additional areas of focus as time allows include:

• Providing general administrative support to the IRO management team (IRO Director, IRO Assistant Director, and IRB Operations Manager).
• Analyzing and processing administrative follow-on submissions for human subjects (IRB) files.

This role applies established policies and procedures and escalates complex or novel issues to IRO leadership. The position involves repeated, high-volume, detailed organizational tasks and administrative processing in a deadline-oriented environment; exceptional familiarity with MS Office; ability to quickly learn new software programs and databases; and special tasks as necessary to support the staff and functions of the IRO. Success in this role also involves ability to work both independently and as a team, the capacity to exercise good judgement and escalate questions appropriately, and a high level of integrity and discretion in handling confidential information. Reports to the IRO Coordinator Supervisor.

Assigned duties involve, but are not limited to, the following areas of responsibility:

1. Verification of Funding and IRB/IACUC Approvals:

• Before funding can be awarded, confirm that all funding source documents (FSDs) include valid approval dates for applicable human and animal research protocols:
  • Support study teams with completing the Funding Verification and Activation Form (FVAF) and Confirmation of Limited Activity Form (CLAF).
  • Confirm funding has appropriate IRB and IACUC approvals.
  • Alert study teams when additional IRB or IACUC submissions are required.
  • Communicate the need to update Hutch IRB or Hutch IACUC databases when information is incomplete or inaccurate.
• Provide IRB/IACUC Certification Letters as requested by investigators, the Fred Hutch Office of Sponsored Research (OSR), or Funding Agencies and Sponsors.

 2. Support Compliance with Training Requirements

• Maintain and audit Human Subjects Protection (HSP) and Good Clinical Practice (GCP) training records in the Learning Management System (LMS) for Cancer Consortium investigators. 
  • Set up and manage logistics for on-going in-house Human Subject Protection training lectures such as:
  • Schedule rooms, request appropriate A/V equipment.
  • Coordinate additional needs – such as catering, copies of materials.
• Provide or confirm completion or certification letters of HSP or GCP training, as requested by staff or OSR.
• Send follow-up email to personnel and their managers 30 days after HSP or GCP expiration.
• Notify IRO Assistant Director of outstanding expired HSP training and GCP training for Cancer Consortium personnel in accordance with IRB policies
• Coordinate updates to Fred Hutch CITI Program account.

3. General Duties Required to Support the IRO Management Team and IRB/IACUC Committees:

• Assist the IRO management team with scheduling meetings, conference calls, reserving conference rooms, etc.
• Work closely with, and in support of, the Chairs by serving as the coordinator and recording secretary for IRO subcommittees.
  • Consult with the IRO Director on preparation of the agenda for subcommittee meetings.
  • Draft meeting minutes within two days but no later than a week of the subcommittee meeting.
  • Follow-up on all IRO subcommittee action items in a timely manner.
• Work closely with the IRO Assistant Director and IRO Coordinator Supervisor to coordinate the annual Joint IRB Meeting and other committee events.
• Process quarterly IRB and IACUC member stipend payments.
• Support the IRO Director in fulfilling all responsibilities as defined in the Office of Director Policy on Human Research Protection Program.
• Assist the IRO Director and other IRO staff, when needed, with expense reports, travel, and conference attendance management

4. General IRO Duties and Support

• Respond to and triage incoming emails to the main IRO email inbox.
• Research applicable policies and forms to independently respond to questions, and escalate complex inquiries as needed.
• Answer and route incoming calls to the main IRO phone line.
• Take minutes at all staff meetings.
• Order office supplies.
• Provide other needed support, as delegated by the IRO Director or IRO Assistant Director.

5. Analysis and Processing of Administrative Modification Submissions for IRB

• Screen administrative IRB submissions for completeness and compliance using standard forms, historical records, and other resources.
• Gather additional data as necessary from researchers, study staff, and others.
• Advise researchers of submission problems and suggest solutions.
• Compose result letters that clearly and accurately communicate IRB approvals to investigators.
• Ensure all documentation (checklists, worksheets, etc.) is complete and accurate as required by business processes.

MINIMUM QUALIFICATIONS:

• Requires High School/GED and four years of administrative or relevant experience OR equivalent education/experience.

PREFERRED QUALIFICATIONS:

• Bachelor’s degree with a minimum of three years administrative experience, or 4 years of progressively complex relevant experience.
• Excellent organizational and communication skills.  
• Attention to detail.  
• Ability to work independently and as part of a team.
• Proficiency in word processing and previous experience with MS Office programs (especially Word, Outlook, and Excel).
• Familiarity with Adobe Acrobat.
• Familiarity with regulatory and/or medical terminology.

The hourly pay range for this position is from $27.01 to $38.45 and pay offered will be based on experience and qualifications.

This position is not eligible for H-1B sponsorship at this time.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).