Cures Start Here. AtFred 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 Hutchs 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 nations first and largest cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The Institutional Review Office (IRO) functions as the central office for managing the ethical review and approval of human or animal studies conducted at Fred Hutch, with specific responsibilities for supporting the Institutional Review Boards (IRBs) and the Institutional Animal Care and Use Committee (IACUC). The Assistant Director oversees the day-to-day operations of the IRO and its relevant committees, proactively identifying and implementing solutions to improve efficiency, effectiveness and timeliness of office processes while maintaining rigorous scientific, ethical and regulatory compliant reviews.
Effectively manage IRO staff supporting two functioning units within the IRO: IRB and IACUC
Effectively oversee the operations of the human subject research and animal care and use programs
Ensure that the budget, staffing and resources for effective day-to-day operations of the IRO are adequate
Evaluate areas of improvement that can streamline IRO review processes, where possible to make them more effective
Attend all IRB and IACUC meetings
Collaborate with research teams and administrative departments interacting with the IRO
Maintain effective relationships with key departments within Fred Hutch with whom the IRO interacts
Be responsive to non-routine activities or information inquiries required by other departments such as legal, media affairs, the Office of the Director or investigator
Provide education and training for research teams and staff responsible for the conduct of human subject and/or laboratory animal research
Develop and maintain basic and refresher human and animal research ethics training in collaboration with the IRB Operations Manager and IACUC Analyst
Deliver human subjects training lectures and animal care and use training lectures as needed
Provide individualized training as needed
Assess ongoing training needs of Fred Hutch and Consortium members
Evaluate training effectiveness with Director
Oversee the IRO quality management system, including policy and procedure management, post-approval monitoring, etc.
Update IRO policies, procedures and education programs when federal regulations, policies or accreditation standards change
Work with IRO Director and QA Manager on AAHRPP accreditation documents and maintain active AAHRPP accreditation status
Evaluate funding proposals and provide certification of IRB/IACUC approval to funding agencies, as required in the absence of the IRO Director
Ensure timely review of scientific proposals undergoing institutional sign-off
Provide IRB and IACUC certifications to funding agencies when required
Bachelors degree; and either six years research protections experience or eight years Fred Hutch experience in a research administrative function; or equivalent combination of education and experience
Minimum 5 years prior supervisory or management experience
Knowledge of research-related policies and regulations, including FDA 21 CFR 50, 56; HHS 45 CFR 46;FDA 21 CFR Part 11
Excellent interpersonal, oral, and written communication skills
Must be highly detail-oriented and organized with intermediate knowledge of Microsoft Word, Excel, Outlook, PowerPoint, and SharePoint
Self-starter, able to work under minimal supervision
Sound judgment in high-demand situations
Experience working with an electronic IRB and/or IACUC system
Demonstrated progressive responsible management experience in research regulation field
Certified IRB Professional (CIP)
Experience implementing electronic submission systems
Experience with process improvement methodologies and techniques
Experience with AAHRPP and/or AAALAC accreditation standards
Experience with audits and inspections conducted by outside agencies or accrediting organizations
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.