CLINICAL TRIAL START-UP COORDINATOR

$72,000 - $85,008/Yr

University of Washington - Bothell, WA

Full-time

Bothell, WA

Educational Services

About the position

The Clinical Trial Start-Up Coordinator is responsible for overseeing the start-up processes of clinical research trials within the Division of Hematology and Oncology at the University of Washington. This role involves working closely with faculty and staff to develop and optimize study start-up processes, ensuring compliance with various regulations, and facilitating communication among stakeholders. The coordinator plays a crucial role in accelerating clinical research by managing study budgets, coordinating submissions, and ensuring timely implementation of clinical trials.

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 for correct post-award invoicing.
• Assess new protocol amendments and identify impacts to study calendars, billing grids, and budgets.
• Collaborate with UW and FHCC clinical teams to assess how to implement protocol 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.
• Unique resources in an environment noted for diversity and intellectual excitement.