IRB Analyst I

Seattle, Washington, Overview 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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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.

Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion. 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. The IRB Analyst 1 coordinates screening, review, and post-review activities for IRB submissions. Primary responsibilities for this position include: Comprehensive analysis of new research studies and follow-on submissions for compliance with regulations, guidelines, and institutional policies. Independent decision-making to move submissions forward; appropriate escalation of significant issues. Efficient and accurate review, processing support, and documentation for all submissions. Respectful, collaborative relationship with all stakeholders. The position requires interpreting and implementing regulations, as well as IRO and institutional policies and procedures, in a deadline-oriented environment.

Success in this role also involves ability to work both independently and as a team, the capacity to exercise good judgement, and a high level of integrity and discretion in handling confidential information. Responsibilities Comprehensive analysis of new research studies and follow-on submissions for compliance with regulations, guidelines, and institutional policies Analyze all levels of submissions for completeness and compliance, using screening forms, historical records, and other resources. Assess submissions for consistency across study documents. Gather additional data as necessary from researchers, study staff, and others. Advise researchers of submission problems and suggest solutions. Advise and provide input to the IRB and other stakeholders regarding regulations, rules and intent, and compliance options. Independently assess whether submissions meet the criteria for a Not Human Research determination. Efficient and accurate review processing support and documentation for all submissions Compose result letters that clearly and accurately communicate basic and complex IRB determinations and/or requests to investigators. Perform quality checks on result letters composed by other IRB Analysts. Ensure all documentation (checklists, worksheets, etc.

) is complete and accurate as required by business processes. Serve as back-up to IRB Analyst 2 and Senior IRB Analyst, Team Lead as needed, including: Develop agendas for, attend, and provide input at monthly and emergency IRB meetings. Communicate with IRB members in order to establish meeting quorum and assign protocol reviews. Respectful, collaborative relationships with all stakeholders Serve in a consultancy capacity by responding to IRB-related questions and concerns initiated by stakeholders. Serve as a liaison between the IRB and research study staff by exchanging information as part of the day-to-day processing of submissions. Share information with colleagues for group and individual learning within the IRO. Provide advice and support to the IRB and other stakeholders. Qualifications Minimum qualifications: Bachelor’s degree and two years Human Subjects review office experience, OR equivalent combination of education and 6yrs experience Demonstrated effective written and verbal communication skills Attention to detail a must Ability to work independently and as part of a team Proficient in word processing and previous experience with MS Office programs (MS Word, Access, Excel) Preferred qualifications: Prior experience as an IRB Analyst Certified IRB Professional (CIP) Working knowledge of federal regulations applying to IRBs, including 21 CFR 50 and 56 and 45 CFR 46 Fred Hutchinson Cancer Center 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, prior to their first day of employment: Provide proof of being fully vaccinated against COVID-19 ; ORInitiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification). 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.

The hourly pay range for this position is from $28. 89 to $41. 14 and pay offered will be based on experience and qualifications. 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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months). 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 hrops@fredhutch. org or by calling 206-667-4700.

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