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The Division of Medical Oncology in the Department of Medicine has an outstanding opportunity for a full-time Research Coordinator.
The purpose of this position is to promote the research objectives of the GI program in the Division of Oncology. This position works with Division of Medical Oncology faculty to facilitate GI development of pharmaceutical-sponsored and investigator-initiated clinical trials, identify research problems and design hypotheses to be tested. This position is responsible for independently designing and implementing multiple research projects to test the hypotheses in human subjects.
This position is constantly required 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 develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the GI program. There are multiple resources available within the University system (e.g. Grant and Contract Services, Institutional Review Board, Office of Industry Relations) to help in this process, but ultimately, the work must be done independently and in a resourceful manner to expedite the GI Program's research objectives. This position is also responsible for organizing and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. Finally, this position interacts with representatives from pharmaceutical companies, health care providers and terminally ill patients in a manner that well-represents the University of Washington and its associated institutions (FHCRC and SCCA).
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 significant contributions to research development, implementation and analysis for the GI Program in the Division of Oncology. It is responsible for overseeing the management of clinical trials, the majority of which provide significant financial support for the GI program. Furthermore, at any one time up to 30 oncology patients from the various GI trials will be enrolled on these clinical trials.
This position must be able to work independently on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, the U.S. Food and Drug Administration, 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.
Analysis and Reporting
Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion.
Work with clinical research involving human subjects within UW Medicine; therefore clinical Research Study Coordinator (RSC) training is required. The training requirement for this position includes UW Medicine-specific as well as general training.
Independently develop and implement research project policies and procedures that meet research objectives 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 (e.g. investigator financial disclosure requirements of the FDA).
Design, develop, document and maintain policies and procedures for protocol registration and implementation to ensure that research execution meets good clinical practice guidelines.
case report forms) as necessary to ensure quality data that correlates with research objectives.
Design, document and implement procedures for protocol audits to assure protocol compliance and to ensure research data quality.
Take action to correct problems such as deviation from protocol requirements to ensure research quality.
Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.
Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens. Ship specimens in accordance with federal and institutional biologics shipping regulations.
Ensure protocol compliance by managing patient appointments and coordinating with patient’s clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.
Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patient’s clinical providers.
Initiate and maintain communication with outside physicians who refer patients to SCCA and/or UWMC for GI oncology clinical trials.
Assist in developing clinical research protocols that clearly describe the research objectives and procedures necessary to test the hypotheses of the research project.
Write informed consent documents that clearly describe the nature and risks of the research project in language that is easily understandable for the individual patient.
Work with multiple UW, SCCA, and Fred Hutchinson Cancer Research Center (FHCRC) groups (e.g. UW Grant and Contract Services, UW Human Subjects Review Committee, UW and SCCA Radiation Safety Committee, UW and FHCRC Biosafety Committee, SCCA Clinical Trials Planning Committee and UWMC General Clinical Research Center) to ensure timely implementation of each research project.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor's Degree in a Health Related Field or science plus a minimum of 1 year experience in clinical, pharmacy or laboratory research project coordination.
Excellent written and verbal communication skills
Experience with Microsoft Office
Being able to work in fast-pace clinical research program.
Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Knowledge of FDA and NIH requirements relating to research involving human subjects
Experience in clinical trial development, implementation and analysis
Previous experience working with oncology patients.
CONDITIONS OF EMPLOYMENT
This position requires a flexible work schedule.
Stringent deadlines from pharmaceutical companies for protocol implementation and data collection may require overtime.
Integrating required elements of research into complex patient schedules (e.g collecting and processing multiple blood specimens for pharmacokinetic sampling) may also require occasional overtime.
Occasional evening and weekend, as well as travel to study meetings is required.
Application Process: The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Workforce Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.
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