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The Department of Urology has an outstanding opportunity for a Research Coordinator to promote the research objectives of the urological oncology program. This position works with Urology faculty to facilitate 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 Urologic Oncology 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 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).
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. Multiple projects will be in progress simultaneously, with the expectation of additional projects in the future.
Protocol Management: •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. •Design, create and revise research instruments (e.g. 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. •Identify and take lead in correcting 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 specimens. Ship specimens in accordance with federal and institutional biologics shipping regulations. •Work collaboratively with research team (research coordinators, faculty, research scientists) to ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Patient Management: •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 urological oncology clinical trials.
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. •Perform other duties as assigned
MINIMUM REQUIREMENTS •Bachelor's Degree and a minimum of 2 years’ experience in health care setting and at least medical assistant phlebotomist certification.
Additional Requirements: •Excellent written and verbal communication skills, experience with Microsoft Office. Being able to work in fast-paced clinical research program. Must have excellent quantitative skills, including high proficiency in Microsoft Excel. •Demonstrated readiness to undertake position responsibilities on one’s own and the ability to work independently. Demonstrated experience self-directing and prioritizing time and workload. •Exceptional organizational skills and attention to detail. Demonstrated ability to methodically develop and document standard operating procedures for recurring tasks.
Equivalent education and/or experience may substitute for minimum requirements.
DESIRED REQUIREMENTS •Master’s degree in psychology, health metrics, nursing, biology, genetics, or related field. •Experience working with oncology patients. Knowledge of FDA and NIH requirements relating to research involving human subjects, experience in clinical trial development, implementation and analysis.
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 travel to study meetings is required. •Regular and predictable attendance 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 Work 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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