Research Coordinator - Department of Medicine, Division of Hematology & Oncology

Research Coordinator

The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Research Coordinator to join their Hematologic Malignancies Research team.

Reporting to a Senior Research Coordinator 3 and under the leadership of the Clinical Research Program Manager, the Research Coordinator 2 is responsible for promoting the research objectives of the UW Hematologic Malignancies Research Program in the Division of Hematology and Oncology. The Research Coordinator 2 is an intermediate level professional research coordinator and will play a key role in developing and implementing procedures for clinical trials that test new treatment therapies.

They will be knowledgeable and observant of all applicable rules, regulations, and guidelines for the safe and ethical conduct of clinical research. This position works under moderate supervision as a member of the Clinical Research Team and works directly with clinical and laboratory-based faculty members who specialize in research targeting a variety of blood disorders, blood cancer, and rare diseases.

The Research Coordinator works on-site at the Fred Hutchinson Cancer Center (FHCC), and occasionally at the UW Medical Center, and may be eligible to be considered for a hybrid telework schedule.

Key Responsibilities

• Collaborate to develop and implement research project policies and procedures that meet research objectives and that ensure compliance with all aspects of Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects.
• Design, develop, document and maintain policies and procedures for protocol implementation to ensure research execution meets good clinical proactive guidelines.
• Design, create, revise, and complete research instruments (e.g. protocol visit checklists, and subject trackers) as necessary to ensure quality data that correlates with research objectives.
• Assist with implementing procedures for protocol audits to assure protocol compliance and research data quality.
• Take action to correct problems such as deviations from protocol requirements to ensure research quality. Assist with creating and implementing CAPA plans.
• Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.
• May process labs for clinical trials, including centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations.
• Ensure protocol compliance by managing patient appointments, including proposing research specific orders within the EMR, and coordinating with patient's clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.
• Support and ensure complete protocol compliance and data collection in clinic. This includes collection of adverse events, concomitant medications, administering quality of life questionnaires, or other procedures required by protocol.
• Understand clinical trial budget and billing plan for patients enrolled on clinical trials. Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance. Assist in financial audits as necessary. Communicate with investigators and fiscal staff when financial milestones have been met.
• Record and track patient protocol visits, including procedures in the CTMS system.
• Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patients' clinical providers and care team.

Analysis and Reporting - 10%

• Prepare interim reports for the research program and sponsors to ensure that each project is moving toward timely completion.
• Attend sponsor and research program meetings and report on progress of each project.
• Assist Regulatory Coordinators by preparing reports to support annual FDA submissions and IRB Continuing Review Reports.
• May perform other duties as assigned. The needs of the Research Program and clinical trial/research portfolio will inform primary allocation of above tasks.

Protocol Development - 5%

• May assist in reviewing clinical research protocols in development to ensure research objectives and procedures necessary to test the hypothesis of the research project are clearly described.
• May work with multiple UW and FHCC groups (e.g. FHCC Clinical Research Support - Clinical Readiness, IDS Pharmacy, Clinical Trials Unit) to help identify operational issues and implement a research project compliantly.

Required Qualifications

• Bachelor's Degree in Life or Social Sciences or related field and 2 years clinical research project coordination experience.

Additional Qualifications

• Experience in clinical trial processes, implementation of research protocols. Sound knowledge of FDA, GCP, and NIH requirements relating to research involving human subjects.
• Strong computer skills and competency with Microsoft Office software. Experience using…