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Regulatory Affairs Associate

Regulatory Affairs Associate

Job ID 
10947
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

The Senior  Regulatory Coordinator is responsible for preparing documentation for industry sponsored, investigator initiated, and national cooperative group clinical trials. The position will prepare IRB documents and other study-related tools for the start-up and management of clinical trials including the IRB application, consent form, study synopsis, annual renewals, modifications, eligibility checklists, and study management tools. The incumbent will report to the CRS Regulatory Operations Manager.

Responsibilities

  • Prepares IRB documents for local and central IRBs including the IRB application, consent form, study synopsis, annual renewals and modifications.
  • Creates and maintains study management templates for CRS to disseminate to study teams such as eligibility checklists, study calendars and patient tracking tools
  • Writes local consent forms from industry templates as well as from investigator initiated protocols
  • Liaises with investigator and study teams to ensure accuracy of documentation
  • Extracts data from Institutional databases to report study accrual data

Qualifications

Experience and Abilities

  • 5+ years working in clinical research environment
  • Reviewing IRB documentation and research protocols
  • Writing technical documents

 

 

Knowledge and Skills

  • Bachelor’s Degree
  • Clinical research related certification preferred
  • Strong verbal and written communication skills
  • Excellent time management skills
  • Advanced knowledge of MS Word and Acrobat

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.