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The University of Washington's Division of Medical Oncology's includes 41 faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Research Center, the Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System. Over the past 25 years, members of the Division have developed the world's leading bone marrow transplant program. In addition, members of the Division have made substantial contributions to many other areas of cancer treatment, including the use of tumor vaccines, cellular therapy for cancer, antibody-based treatments, and novel forms of chemotherapy and hormonal therapy. Our Division is deeply committed to maintaining its position as one of the leading centers for research and treatment of cancer in the world.
The Division of Medical Oncology has an outstanding opportunity for a full-time Research Coordinator. The purpose of this position is to promote the research objectives of the Breast/Oncology research program in the Division of Oncology. This position works with Division of Medical Oncology faculty to facilitate investigator- initiated and pharmaceutical-sponsored clinical trials, identify research problems and design hypotheses to be tested. This position is responsible for implementing multiple research projects to test the hypotheses in human subjects.
The Division of Oncology is physically located in the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center campus. This position requires operational knowledge of the University of Washington, Fred Hutchinson Cancer Research Center, and Seattle Cancer Care Alliance.
This position requires understanding the research process and ability to integrate this knowledge with research priorities to implement program goals.
The mission statement of the University of Washington Medical Center states that the Medical Center serves as a research resource, providing an environment in which clinical research may be conducted. This position is essential to that mission. This position provides contributions to research development and implementation for the Division of Oncology. It is responsible for overseeing the management of clinical trials, the majority of which provide significant financial support for the Division of Oncology. Furthermore, at any one time up to 100 oncology patients from various Phase I,II and III oncology trials will be enrolled on these clinical trials.
This position must be able to work independently on multiple research projects with minimal written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 10 projects will be in progress simultaneously, with the expectation of additional projects in the future.
With minimal guidance 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).
Develop, document and maintain procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
Assist in the design, creation and revision of research instruments (e.g. case report forms, AE logs, Study guides) as necessary to ensure quality data that satisfies research objectives.
Create and maintain complete source documentation for patients on assigned studies.
Work with Regulatory Coordinator to ensure that reporting to the Institutional Review Board and study sponsors are timely, accurate and satisfy applicable regulation. With minimal guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity.
Work collaboratively with research team (data coordinator, regulatory coordinator, research assistant) to ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Assist in preparing and conducting sponsor monitoring visits.
Serve as protocol expert for assigned studies.
Be the site research coordinator for studies conducted through the Translational Breast Cancer Research Consortium (TBCRC), and attend teleconferences and meetings as required.
Implement research protocols at SCCA and UWMC, integrating research and clinical requirements to ensure patient safety and protocol compliance. Communicate research requirements effectively with all providers involved in patient care. Manage complex patient schedules. Align research requirements and clinical care to ensure collection of accurate and reliable data.
Assist in ensuring patient safety while participating on a clinical trial by monitoring patients and interacting closely with the patient's clinical providers.
Communicate with outside physicians who are interested in referring patients to UWMC/SCCA for clinical trials.
Retrieves data from patient charts and/or source documents, abstracts information from complex medical records and reports for entry into sponsor provided case report forms. Case report form may be paper based or electronic. CRF completion and data entry responsibility may be shared with other team members, necessitating accurate and timely communication with all team members. Prepares source data documents to collect/support all data associated with research protocols.
Work independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Code and record said information into various study-specific data- capture systems (both electronic and paper-based).
Work professionally with sponsor representatives to review and correct data recorded in the case report forms. Exercise independent judgment on query resolutions.
Promotes a proactive and professional relationship with internal and external staff and affiliates.
Maintains strictest confidentiality.
Actively participates in meetings and/or training as required.
Serves as subject matter and protocol expert for assigned studies.
Works with Manager and fellow team members to insure adequate staffing levels for Program, including helping to cover sick call, vacations, etc.
Responsible for maintaining computer spreadsheets and databases for research studies.
Understand research study flow, work with clinic staff, support services and research team as needed to implement clinical trials.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.