IRB Coordinator

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 Comprehensive Center for the Advancement of Scientific Strategies (COMPASS) IRB Coordinator reviews research activities involving human subjects to uphold ethical standards and to ensure research activitiescomply with all pertinent regulations and Fred Hutch policies. The position requires interpreting and implementing regulations, as well asIRO and institutional policies and procedures, in a deadline-oriented environment. Success in this role also involves ability to work bothindependently and as a team, the capacity to exercise good judgement, and a high level of integrity and discretion in handling confidential information.

• Prepare all submissions and query responses for the Early Detection Research Network (EDRN) in a timely manner to the Institutional Review Office (IRO), other external committee as appropriate (e.g. radiation safety review) to assure the protection of human subjects in research, including but not limited to: Initial Application, Modification, Continuing Review, Safety Reports, non-compliance, Confidentiality Agreement.
• Prepare and maintain regulatory documents: Investigator 1572 forms, Financial Disclosure Forms, CVS, Medical licenses, Monitoring reports.
• Manage the protocol activation process and track the required documents and activities needed for protocol activation. Perform review of documents for completeness and accuracy. Distribute approved documents to study team to communicate that the study/activity is approved, in a timely manner.
• Ensure that reporting requirements are met.
• Ensure that research staff have met the standard training requirements regarding Human Subjects and GCP trainings as well as documenting completion of study specific training.
• Develop and provide ongoing regulatory-related education and training for investigators and research team members. Work with study team to implement study specific training (e.g. protocol amendment training).
• Work with Fred Hutch Office of Business Develop-Strategy, as well as the collaborating organization(s) to prepare data and material transfer and use agreements (DMTUA)/Collaboration Agreements (Consortia Specific or Project Specific) between international and domestic sites.
• Update and manage the regulatory tracking and archive systems (e.g. SharePoint, OneDrive, OnCore, Hutch IRB). Perform periodic QA/QC to ensure that the information added is accurate and complete.
• Respond to queries with sponsors, regulatory committees, and staff in a timely manner.
• Provide guidance to investigators and staff to ensure the study is being conducted as outlined in the latest institutional review board (IRB) approved protocol.
• Work with manager and leadership to develop standard operating procedures (SOPs).
• Coordinate and manage the regulatory documents from each participating site for studies where Fred Hutch serves as the IRB of record (coordinating center). Also track sites’ annual continuing reviews and alert sites to upcoming expirations to prevent lapses from occurring.
• Be responsible for archiving regulatory documents/records, ensuring that all files are prepared for off-site storage in accordance with FDA, other applicable regulatory guidelines and program SOP.
• Maintain and update tracking systems.
  
  

MINIMUM QUALIFICATIONS:

• HS and three years complex administrative experience in professional setting, OR equivalent combination of education andexperience.
• Demonstrated effective written and verbal communication skills.
• Attention to detail is 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) required.

PREFERRED QUALIFICATIONS:

• Bachelor’s degree
• Prior experience in a Human Subjects review office or legal/medical office
• Training in Human Subjects and Good Clinical Practice
• Minimum of five years in the cancer research field
• CIP certified (certified IRB professional)

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.

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The hourly pay range for this position is from $26.99 to $38.43 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). 

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 Human Resources at hrops@fredhutch.org or by calling 206-667-4700.