Regulatory Coordinator, Institution-Sponsored IND Program

Company: Fred Hutchinson Cancer Research Center
Location: Seattle
Posted on: September 24, 2022

Job Description:

Overview
Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch's global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
The Regulatory Coordinator is responsible for providing support to investigators and others within the Cancer Consortium (Fred Hutch, UW, Seattle Children's) on regulatory issues and requirements related to the conduct of clinical trials and use of investigational products. The incumbent will facilitate communications with the FDA, provide support to study teams in the preparation and review of FDA submissions and other regulatory documents, and assist with FDA inspections. This position will represent the Institution-Sponsored IND Program. The incumbent will work under the direction of the IND Operations Manager.
Responsibilities

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• Reviews and edits routine submissions to FDA including IND amendments, annual reports, and safety reports
  
• Provides formatting and editing assistance for institution-sponsored IND trial documents, including protocols and consent forms
  
• Assembles and submits regulatory packages to the FDA to obtain initial protocol and amendment approvals for institution-sponsored IND trials
  
• Creates, maintains, and updates IND management templates for institution-sponsored IND program
  
• Establishes and maintains Cancer Consortium and Sponsor regulatory files, including filing essential correspondence and submission information in real time
  
• Facilitates SAE processing to comply with FDA reporting requirements for IND trials
  
• Extracts data from institutional databases to report study accrual data
  
• Extracts data from study databases for scheduled and ad hoc reports for ongoing review of safety data and IND annual reports
  
• Triages correspondence for institution-sponsored IND trials in real time
  
• Responsible for monitor visit preparation and follow-up
  
• Facilitates communication between study teams and medical monitors for institution-sponsored IND trials
  
• Assist with development and implementation of SOPs for the ISIOC program
  
  Qualifications
  EXPERIENCE AND ABILITIES
  
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  • 1-3 years working in regulatory affairs with emphasis on INDs and IDEs in a pharmaceutical, biotechnology, or academic clinical research setting
    
  • Formatting and editing protocols, informed consents, or other scientific documents
    
  • Preparing and reviewing IND applications
    
  • Communicating with FDA and preparing for FDA inspections
    
  • 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
    
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    • Bachelor's Degree required
      
    • Master's degree preferred, ideally in healthcare related field
      
    • Clinical research-related certification preferred -
      
    • Familiarity with process improvement principles and project management
      
    • Excellent written and verbal communication skills
      
    • Knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and Good Clinical Practice
      
    • Ability to work collaboratively and build relationships across large organizations
      
      In addition to job duties at Fred Hutch, this position also requires access to Seattle Cancer Care Alliance, which requires COVID-19 vaccination without exceptions.Accordingly, as a condition of employment for this Fred Hutch position, newly hired employees must provide proof of vaccination before their first day of employment.
      A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
      Our Commitment to DiversityWe are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, 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 hrops@fredhutch.org or by calling 206-667-4700.

Keywords: Fred Hutchinson Cancer Research Center, Seattle , Regulatory Coordinator, Institution-Sponsored IND Program, Other , Seattle, Washington