Senior Regulatory Coordinator

Job ID
17702
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Clinical Research Support Services

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.

 

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 department of Clinical Research Support (CRS) is the central clinical trials office for the University of Washington/Fred Hutchinson Cancer Research Center Cancer Consortium. The CRS Operations Coordinator is responsible for preparing documentation for industry sponsored, investigator initiated, institution-sponsored IND, and national cooperative group clinical trials. The position will prepare FDA and IRB documents and other study-related tools for the start-up and management of clinical trials, maintain regulatory files, and facilitate SAE processing. This position will report to the Regulatory Operations Manager.

 

Responsibilities

  • Prepares and submits regulatory documents to the IRB to request initial, yearly, and protocol amendment approvals for industry sponsored, investigator initiated, institution sponsored IND, and national cooperative group clinical trials
  • Prepares and submits regulatory documents to the FDA to obtain initial protocol and amendment approvals for industry sponsored and institution-sponsored IND trials
  • 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
  • Establishes and maintains Cancer Consortium and Sponsor regulatory files
  • Facilitates SAE processing to comply with FDA reporting requirements for IND trials
  • Provides formatting and editing assistance for institution-sponsored IND trial documents
  • Extracts data from Institutional databases to report study accrual data
  • Extracts data from study data bases for scheduled and ad hoc reports for ongoing review of safety data, and IND annual reports

Qualifications

  • Bachelor’s degree required
  • At least 3 years regulatory experience in a clinical research environment
  • Clinical research related certification preferred
  • Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)
  • Reviewing IRB documentation and research protocols
  • Experience writing technical documents
  • Ability to work collaboratively and build relationships across a large organization
  • Excellent written and verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing
  • Excellent time management skills
  • Advanced knowledge of MS Word and Acrobat

Our Commitment to Diversity

We 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 HR Operations at HRops@fredhutch.org or by calling 206-667-4700.

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