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 Regulatory Coordinator is responsible for preparing and processing submission documentation for clinical trials and investigator-initiated clinical research. The position will prepare FDA, IRB and IBC documents and other study-related tools for the start-up and management of clinical research, maintain regulatory files, and facilitate onsite processing at the Vaccine Trials Unit clinical location(s).
Provides regulatory support to investigators and staff throughout the lifecycle of a clinical trial or clinical research protocol
Writes, prepares and submits complex IRB/IBC submissions including applications, renewals, amendments, consent forms, safety reports, etc. in accordance with required timelines
Prepares and coordinates site registration (RSC) materials/submissions and assist with communications with sponsors
Develops internal processes, tools/templates, and standard operating procedures for the clinical research team
Along with the PI and Regulatory Manager, tracks all clinical activity documents for the Vaccine Trials Unit (VTU) including IRB/IBC/RSC approvals, safety reports, deviations, laboratory certifications, staff training & licenses, monitoring notices and reports, inspections & compliance, etc.
Assures the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments
Assists in the coordination of project activities to ensure they follow timelines and meet deadlines
Assists in the development of research materials
Performs information searches related to studies and projects
Provides clear and concise professional communication
Uses judgment to interpret and apply federal and local regulations regarding clinical research
Performs other responsibilities as assigned
High school diploma or equivalent
Minimum of one year of regulatory, human research protection or related experience in a research environment
Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)
Ability to work collaboratively and build relationships across a large organization
Excellent written and verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing
Excellent time management skills
Advanced knowledge of MS Word and Acrobat
Skilled in the use of clinical trials and electronic document management systems
Associate’s or Bachelor’s degree in a related field
2-3 years working in clinical research with emphasis on IRBs, Ethics Committee and Human Subjects review for a pharmaceutical, biotechnology, or academic clinical research setting
Regulatory and/or Clinical research-related certification (RAPS, ACRP, SOCRA)
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 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).
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 $26.20 to $37.31 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).