CLINICAL TRIAL START-UP COORDINATOR

$72,000 - $85,008/Yr

University of Washington - Seattle, WA

Full-time - Mid Level

Seattle, WA

Educational Services

About the position

The Clinical Trial Start-Up Coordinator at the University of Washington is responsible for overseeing the start-up processes of clinical research trials within the Division of Hematology and Oncology. This role involves developing and optimizing study start-up processes, managing study budgets, and ensuring compliance with various regulatory requirements. The coordinator will work closely with faculty, research staff, and external partners to facilitate the timely initiation of clinical trials, thereby contributing significantly to the success of the Hematology Clinical Research Program.

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.
• Develop and track study start-up report progress with metrics to Research Managers and faculty.
• Train and guide study team members regarding CTMS entry requirements.
• Assess new protocol amendments and identify impacts to study calendars and budgets.
• Collaborate with UW and FHCC clinical teams to assess how to implement protocols in relevant service areas.
• Independently develop and implement research project procedures and tools that meet research objectives.
• 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 and competing deadlines.
• Excellent written and verbal communication skills.
• Strong computer skills and competency with Microsoft Office software.

Nice-to-haves

• Experience working within the UW/FHCC setting.

Benefits

• Generous benefits and work/life programs
• Professional growth opportunities
• Diversity and inclusion initiatives
• Access to unique resources in a supportive environment