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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 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.
This position requires understanding the research process and ability to integrate this knowledge with research priorities to implement program goals. With guidance, this position develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Division of Oncology. 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 with limited assistance and in a resourceful manner to expedite the Division’s research objectives. This position is also responsible for participating in 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 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 satisfy 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 (IRB) 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.
Bachelor's degree in life sciences plus a minimum of 1 year experience in oncology and experience in research setting
Data analysis and entry, excellent written and verbal communication skills, experience with Microsoft Office
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.
Previous experience working with oncology patients
Previous experience conducting research in a hospital or academic setting
CONDITIONS OF EMPLOYMENT
The position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center. Travel to/from campus buildings is required.
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.
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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