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Protocol/Operations Coordinator I

Protocol/Operations Coordinator I

Job ID 
9267
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 and largest 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 Protocol/Operations 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 Study Support Services Regulatory 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

  • 2-3 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