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Regulatory Coordinator

Regulatory Coordinator

Job ID 
Regular Full-Time
Fred Hutchinson Cancer Research Center
Clinical Research Support Services

More information about this job


Cures Start Here. At Fred 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 Hutch’s 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 nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Regulatory Coordinator works in coordination with other Study Startup team members to perform comprehensive study startup support. The Regulatory Coordinator will be responsible for expeditious coordination of the regulatory submissions in the study startup phase to support key metrics reported to institutional leadership. At any given time, there will be 5 to 15 trials actively in startup. The incumbent will report to the Start-Up Operations Manager.



  • Prepare and submit required internal and external submissions over the course of study startup and site activation. These include, but are not limited to the submissions to an Institutional Review Board (central or local), the Institutional Biosafety Committee, the Radiation Safety Committee, and the Scientific Review Committee.
  • Write informed consent forms in accordance with GCP and FDA guidelines, ensuring all appropriate elements of informed consent.  Must be able to explain complicated research protocol requirements to research participants using easily understood language.
  • Integrate information from multiple sources and use specialized knowledge of institutional, state, and federal requirements to ensure compliance with those entities.
  • Understand the timing and implications of other team members’ startup requirements to ensure accurate and effectively timed submissions.
  • Liaise with investigators, industry sponsors, and study teams to ensure accuracy of documentation.
  • Create, manage, and supply supportive documents such as 1572s, financial disclosures, laboratory accreditations, laboratory reference ranges, CVs, medical licensures, delegation of authority logs, and required training documentation.
  • Create tools to support organized startup efforts to be used within the team, Clinical Research Support, and the Cancer Consortium.


Experience and Abilities

  • 3+ years working in clinical research environment (oncology preferred)
  • Demonstrated ability to write informed consent documents
  • Experience using central and local IRBs
  • Ability to interpret and apply local, state, and federal requirements



Knowledge and Skills

  • Bachelor’s Degree
  • Clinical research related certification preferred
  • FDA, GCP, and NIH requirements relating to research involving human subjects  
  • Strong verbal and written communication skills
  • Excellent time management skills
  • Advanced knowledge of MS Word and Acrobat