Clinical Research Coordinator

2 days ago

Seattle, Washington, United States University of Washington Full time
Job Title: Clinical Trial Start-Up Coordinator

We are seeking a highly organized and detail-oriented Clinical Trial Start-Up Coordinator to join our team at the University of Washington.

Job Summary:

This position is responsible for the clinical research start-up processes for industry-sponsored and investigator-initiated clinical trials in the Division of Hematology and Oncology.

Key Responsibilities:
  • Establish confidentiality disclosures between UW and industry sponsors, and partner with the UW Office of Sponsored Programs to ensure appropriate documents are in place.
  • Review clinical trial protocols for feasibility and site selection forms; communicate with Sponsors about site capabilities.
  • Coordinate facility tours and visits with sponsors to demonstrate site qualification.
  • Triage and review site selection letters and receipt of comprehensive start-up package.
  • Create, update, and maintain Clinical Trial Management Systems entries for all protocols.
  • Facilitate submission of new study start-up documents to relevant offices within UW and FHCC departments.
  • Interpret complex human subject protocols, with a thorough understanding of medical terminology and clinical processes, to determine adequate budgeting for protocol tasks and assessments.
  • Ensure that budgets meet compliance standards for both clinical and financial aspects.
  • Review and approve all clinical trial study visit calendars, protocol assessment billing designations, and protocol specific details in the institution's Clinical Trial Management System.
  • Ensure clinical trial registration with the appropriate service areas, develop clinical trial management and tracking documents, create protocol-specific workflow and checklist tools.
  • Collaborate with Regulatory Coordinators to ensure appropriate regulatory approvals are in place, and training and delegations are completed.
  • Forecast, track and report study start-up timelines.
  • Develop and track study start-up report progress, with metrics, to Research Managers, faculty, and study team members.
  • Train and guide study team members regarding CTMS entry requirements for correct post-award invoicing and to accurately interpret clinical trial budgets for proper invoice approval.
  • Assess new protocol amendments and identify impacts to study calendars, billing grids, and budgets. Amend existing study budgets to support changes in protocol and/or correct errors.
Requirements:
  • Bachelor's degree in science or health-related field.
  • At least two years of experience in clinical research working with human subjects.
  • Working in hematology and/or oncology.
  • Experience working within the UW/FHCC setting.
  • Familiarity with Epic electronic health record system.
  • Knowledge of HIPAA regulations, GSP and HSD training, and FDA guidelines relating to research involving human subjects.
  • Strong attention to detail and ability to multi-task, organize, and prioritize projects and competing deadlines.
  • Excellent written and verbal communication skills.
  • Strong computer skills and competency with Microsoft Office software.
Working Conditions:

This position is located in a clinical research environment at the Fred Hutchinson Cancer Center campus and requires the physical ability to get between offices, clinic, and other facilities, up to 1-mile distance.

This position requires a flexible work schedule and may require overtime to meet deadlines from sponsors and faculty for protocol implementation.

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