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Regulatory Coordinator I

Regulatory Coordinator I

Job ID 
10634
Type 
Regular Full-Time
Company 
Fred Hutchinson Cancer Research Center
Location 
US-WA-Seattle
Category 
Clinical Research Support Services

More information about this job

Overview

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.

 

Fred Hutch is hiring a highly motivated regulatory coordinator to support ongoing trials and study initiation for the Immunotherapy team.  Clinical research studies in the program include both investigator-initiated and industry-initiated protocols.  The Clinical Research Regulatory Coordinator is responsible for preparing and managing documentation for industry-sponsored and investigator-initiated clinical trials. The incumbent will prepare IRB documents and FDA correspondence, maintain regulatory files, and facilitate regulatory oversight of safety reporting.

Responsibilities

Key Responsibilities

  • Prepares IRB documents for local and central IRBs including the IRB application, informed consent form, study synopsis, annual renewals, and modifications.
  • Prepares and submits FDA correspondence for investigator-initiated trials.
  • Liaises with Investigators and Immunotherapy study team to ensure accuracy of documentation
  • Maintains regulatory files including IND, Investigator, Manufacturing, and Trial Master Files (Sponsor).
  • Collaborate with data team to extract data from study databases for scheduled and ad hoc reports for ongoing review of subject accrual data, safety data, and IND annual reports.
  • Ensure sponsor oversight and reporting
  • With the research manager, coordinates monitoring and auditing visits with Clinical Research Support (CRS), industry sponsors, and third party auditors.

Qualifications

 Experience and Abilities

  • 2-3 years of clinical research regulatory coordinator experience or equivalent formal education
  • Reviewing IRB documentation and research protocols
  • Writing technical documents

Knowledge and Skills

  • Bachelor’s degree required; Master’s degree in regulatory affairs preferred
  • Knowledge of FDA, ICH/GCP guidelines
  • Clinical research related certification preferred
  • Strong verbal and written communication skills
  • Excellent time management skills
  • Advanced knowledge of MS Word and Excel

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, 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 escmail@fredhutch.org or by calling 206-667-4700.