Research Coordinator Department of Medicine, Division of Hematology & Oncology

Position: Research Coordinator 3 -- Department of Medicine, Division of Hematology & Oncology
Job Description The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Lead Clinical Trials Specialist to join their Thoracic, Head & Neck Oncology Clinical Trials Research Program.

About this Opportunity Reporting to the Clinical Research Implementation Project Manager of the UW Thoracic, Head & Neck Oncology Research (THOR) Program, the Lead Clinical Trials Specialist (CTS) (Research Coordinator
3) provides operational leadership for investigator-initiated and industry-sponsored clinical trials, overseeing study start-up, protocol amendments, contract execution, budget development, and ongoing financial and regulatory maintenance across UW and FHCC clinical trials and grants management systems. This role is a fully functional, professional research coordinator that provides daily guidance and technical assistance to promote management, integrity, and continual improvement of work practices of clinical trial research in the program.

This position serves as a key liaison across multiple stakeholders, including FHCC and UW clinical and administrative departments, regulatory committees, pharmaceutical sponsors, Clinical Research Organizations (CROs), and external academic institutions. This position will engage with multiple clinical trials simultaneously, with the expectation of additional projects in the future.

The Lead Clinical Trials Specialist works on-site at the Fred Hutch Cancer Center (FHCC), and project work visits may be required during the work shift at local affiliate locations. The position may be eligible to be considered for a hybrid telework work schedule based on business needs, working remotely up to two day per week, once fully trained and demonstrating telework readiness.

Key Responsibilities Coordinate clinical trial start-up processes (40%)Establish and maintain methods to initiate study start-up budget and implementation planning, delegate tasks, and provide forecasting of start-up workloads.

Use knowledge of clinical research, medical terminology, and clinical processes to translate complex oncology protocol requirements into clinical trial budgets and facilitate submissions to relevant compliance offices.

Work with program leadership and faculty to ensure appropriate study start-up pricing and budget efforts into study tracking.

Independently negotiate successful clinical trial budgets and payment terms with study sponsors, per the program's set requirements.

Guide regulatory staff for timing of necessary submissions (Scientific Review Committee, UW Human Subjects Division, Radiation Safety, FDA submissions, and IRB submissions), in order to meet projected start-up deadlines.

Coordinate and communicate with UW and FHCC offices involved in the review and negotiation of clinical trial budgets and contracts, including UW Clinical Trial Office (CTO), the UW Office of Sponsored Programs (OSP), and the FHCC Clinical Research Support (CRS) office.

Prepare and submit eGC1s in accordance with CTO requirements and deadlines.

Ensure SFI compliance is completed and required approvals are received by CTO deadlines.

Create Advanced Budget Numbers and work tags.

Assist research and finance program managers with developing communicating study start-up metrics and goals.

Forecast, track and report study start-up timelines.

Produce monthly and quarterly study start-up metric reports using established formats.

Coordinate with UW and FHCC offices and clinical areas to arrange for clinical services and orders.

Budget and Contract Amendments (30%)Review protocol amendments and new study materials for changes that impact billing, budget and research orders that impact clinical and financial implementation.

Process budget and contract amendments and…