CLINICAL TRIAL START-UP COORDINATOR

UW Medicine - Seattle, WA

Full-time - Entry Level

Seattle, WA

Ambulatory Health Care Services

About the position

The University of Washington (UW) is seeking a Clinical Trial Start-Up Coordinator for the Department of Hematology and Oncology. This position is responsible for the clinical research start-up processes for industry-sponsored and investigator-initiated clinical trials. The coordinator will work closely with faculty in the Acute Leukemia, MDS/MPN, and Classical Hematology disease groups to enhance the efficiency of clinical research start-up by developing and optimizing processes. The role requires a thorough understanding of the clinical research process and the ability to integrate this knowledge with research priorities to create robust study budgets. The coordinator will guide studies through internal and external start-up processes and approvals, ensuring compliance with various policies and guidelines.

Responsibilities

• Establish confidentiality disclosures between UW and industry sponsors.
• 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.
• 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 to determine adequate budgeting for protocol tasks and assessments.
• Review and approve all clinical trial study visit calendars and protocol-specific details in the Clinical Trial Management System.
• Ensure clinical trial registration with appropriate service areas and develop tracking documents.
• Collaborate with Regulatory Coordinators to ensure appropriate regulatory approvals are in place.
• Forecast, track and report study start-up timelines.
• Train and guide study team members regarding CTMS entry requirements.
• Assess new protocol amendments and identify impacts to study calendars, billing grids, and budgets.
• Collaborate with clinical teams to assess how to implement protocols in relevant service areas.
• Independently develop and implement research project procedures and tools.
• Design, develop, document, and maintain policies and procedures for protocol implementation.
• Coordinate and oversee vendor access for clinical trial databases and systems.
• Schedule and oversee Site Initiation Visits for clinical trial activation.

Requirements

• Bachelor's degree in science or health-related field.
• At least two years of experience in clinical research working with human subjects.
• Experience working in hematology and/or oncology.
• 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.

Nice-to-haves

• Experience working within the UW/FHCC setting.
• Strong computer skills and competency with Microsoft Office software.

Benefits

• Generous benefits and work/life programs.
• Professional growth opportunities.
• Unique resources in a diverse and intellectually stimulating environment.