Clinical Research Coordinator
2 days ago
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.
- 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.
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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