Research Coordinator 2 - 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 Thoracic, Head, and Neck Oncology Research team.

Reporting to the Research Manager of the UW Thoracic, Head, and Neck Oncology (THOR) Research Team, the Research Coordinator 2 is responsible for promoting the research objectives of the Division of Hematology and Oncology in the THOR Clinical Trials Research Program. The Research Coordinator 2 will play a key role in implementing clinical trials that test new cancer therapies. This position is an intermediate level professional research coordinator and, working under moderate supervision, is required to use independent judgement, leadership and expert knowledge to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor.

This position will work as a member of the Clinical Research Team and with faculty, staff and departments across multiple institutions to implement and coordinate investigator-initiated and pharmaceutical-sponsored clinical trials.

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

This position must be able to work independently under administrative direction on multiple clinical trials without benefit of written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, providers, other health care personnel (e.g., nurses, patient care coordinators, insurance companies), and patients. This position will manage multiple clinical trials, including out-patient and in-patient elements, with the expectation of additional projects in the future.

Protocol Management – 60%

• Collaborate to develop and implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA), and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g., investigator financial disclosure requirements of the FDA).
• Design, develop, document and maintain processes for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
• Design, create, revise and complete research instruments (e.g., protocol visit checklists, subject trackers) as necessary to ensure quality data that correlates with research objectives.
• Assist with implementing procedures for protocol audit 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.
• Work collaboratively with research team (data manager, regulatory coordinator, research assistant) to ensure that projects are executed successfully and completed within required time frames to meet research objectives.

Patient Management - 25%

• 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…