Research - Laboratory/Non-Laboratory, Staff/Administrative
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The University of Washington, Division of Medical Oncology has an excellent position for a Clinical Research Data Coordinator in the Phase I Clinical Trials Research Program.
The purpose of this position is to promote the research objectives of the Phase 1 Program in the Division of Oncology (www.seattlecca.org/clinical-trials/phase1.cfm). This position works with Division of Medical Oncology faculty to facilitate Phase 1 and other early development 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.
The Data Coordinator will work with the research team to collect and abstract clinical data from medical records and research charts, work closely with the physicians and research staff in providing administrative and technical support for research projects, and will follow complex instructions for processing laboratory samples (including tumor tissue samples) for tracking, storage, or shipping.
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 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 the Phase I Program 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 physicians, other health care personnel (e.g. nurses, patient care coordinators, patient service representatives, medical assistants), pharmaceutical company sponsors and any other groups integral to the successful completion of the research project.
Data Coordination, Abstraction and Analysis
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).
Resolve and answer data queries with minimal errors.
Make independent judgments about the relevance of the clinical data to the research for complicated oncology research subjects.
Create and maintain patient shadow charts (paper and eCharts)
Principally responsible for maintaining computer spreadsheets and databases for research studies.
Understanding research study flow, work with clinic staff support services and research team members to set-up research subject appointments at required intervals.
With study team, draft study specific visit checklists to meet study protocol needs.
Independently develop study-specific or program data acquisition forms.
Work professionally with sponsor representatives to review and correct data recorded in the case report forms. Exercise independent judgment on query resolutions.
Schedule monitoring visits with sponsor representatives and request electronic medical records access for their visits.
Request medical records and archival tumor tissue when required from outside medical facilities.
Clinical Trial Management System (CTMS) Data Entry
Enter completed patient visits, protocol deviations and additional data points into CTMS system.
Collaborate with members of Phase I Program team to ensure data entry is up to date and accurately reflects activities relating to research.
Collate and maintain clinical information from multiple sources into research charts, eCharts, study binders, etc.
Independently track and maintain research subject schedules based on complex protocol-specific requirements.
Assist with retrieval and return of oral investigational agents to IDS pharmacy.
Interact with patients at study visits to collect data.
Perform protocol mandated ECGs.
Collect tissue from fresh tumor biopsies (SCCA, UWMC, Harborview, etc.)
Assist Research Coordinators in insuring proper billing of research charges.
Research Specimen Tracking and Coordination
Assist Phase I Lab with tracking laboratory sample supplies, completing requisition forms and answering central laboratory as needed.
Assemble archival and fresh tumor tissue laboratory kits and ship samples per central laboratory manual guidelines.
Assist Phase I Lab with tracking research subject blood, urine, and tissue samples following study specific guidelines for storage and/or shipping as needed.
Assist Investigators and study team with preparation and analysis of study data for publication and grant preparation. Perform related tasks as assigned.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
BA/BS in a science-related field and one year of experience in the medical field; OR equivalent combination of education and related experience.
Demonstrated understanding of medical terminology
Strong computer skills and experience with data entry and databases
Strong attention to detail and ability to organize work
Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues, research subjects, and study sponsor representatives
Demonstrated ability to work independently and to carry out complex tasks
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Knowledge of Oncology practice and terminology
Prior working experience at the UWMC, FHCRC, and/or SCCA
Prior experience in basic processing laboratory samples
Competency in Microsoft Office software
Competency in Allegro and OnCore CTMS software
Knowledge of HIPAA regulations
Knowledge of GCP (Good Clinical Practice)
CONDITIONS OF EMPLOYMENT
This 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 campus. Work hours frequently exceed 40 hours per week and can be deadline dependent. At least one second shift per week 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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