Clinical Research Coordinator III
Fred Hutchinson Cancer Research Center - Seattle, WA

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Fred Hutchinson Cancer Research Center, home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. The Hutchinson Center, in collaboration with its clinical and research partners, the University of Washington and Seattle Children’s, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. Join us and make a difference!

The Clinical Research Coordinator is responsible for providing support on regulatory issues and requirements both prior and during the conduct of clinical trials. The incumbent will oversee communications with the FDA, provide direct support to study teams in the preparation of regulatory documentation and assist with FDA audits. This position will work with the Kiem laboratory by making presentations to staff, disseminating tools and information, and meeting with study teams on an ad hoc basis.

Responsibilities
Key Responsibilities
  • Provides proactive regulatory consultation and support throughout the lifecycle of a clinical trial
  • Provides representation and direct support to sponsor-investigators, clinical investigators, and staff with FDA communications including support during FDA inspections
  • Prepares and reviews INDs/IDEs, request for IND exemptions, expanded access INDs, amendments, annual reports, and safety reports for investigators
  • Directs the development of templates and tools for study teams conducting studies under INDs/IDEs
  • Develops internal processes and standard operating procedures for reviewing activity
  • Provides regulatory support as needed for clinical monitoring activities
  • Develops comprehensive tracking system for regulatory affairs activity
  • Serves as regulatory affairs subject matter expert
  • Serves as liaison between manufacturing, quality, IRO, legal counsel and CRS management
  • Provides current regulatory expertise attending related project meetings, conferences, and participating in professional associations

Qualifications

Experience and Abilities
  • 3 - 5 years working in regulatory affairs with emphasis on INDs and IDEs in a pharmaceutical, biotechnology, or academic clinical research setting
  • Preparing and reviewing IND applications
  • Communicating with FDA and preparing for FDA audits
  • Assessing risk in the conduct of clinical research
  • Designing tools for the regulatory management of clinical trials
  • Interpreting federal regulations and guidelines
  • Working with all levels of a research team

Knowledge and Skills
  • Bachelor’s Degree
  • Master’s degree healthcare related field preferred
  • Clinical research related certification preferred
  • Familiarity with process improvement principles
  • Strong verbal and written communication skills
  • Knowledge of regulations and guidelines that govern clinical research and manufacturing, including, but not limited to FDA, cGCP, cGMP regulations
  • Ability to work collaboratively and build relationships across large organizations
We are a VEVRAA Federal Contractor.

Fred Hutchinson Cancer Research Center - 30+ days ago - save job - block
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