CLINICAL RESEARCH DATA COORDINATOR
University of Washington
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CLINICAL RESEARCH DATA COORDINATOR

University of Washington

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Details
Posted:
March 7, 2021
Location:
Seattle, Washington
Salary:
Open
Type:
Full Time

Research CoordinatAs a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem solving skills and dedication to build stronger minds and a healthier world.

UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty.

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.

Position Complexities

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.

Position Dimensions and Impact to the University

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.

Duties and Responsibilities

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.

    Protocol Coordination

  • 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.

    Patient Contact

  • Interact with patients at study visits to collect data.
  • Perform protocol mandated ECGs.
  • Collect tissue from fresh tumor biopsies (SCCA, UWMC, Harborview, etc.)

    Research Billing

  • 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 a complete description of our benefits for this position, please visit our website, click here.

    REQUIREMENTS

  • BA/BS in a science-related field and one year of experience in the medical field; OR equivalent combination of education and related experience.

    Additional Requirements:
  • 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.

    DESIRED

  • 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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    Internal Number: 188028
    About University of Washington
    Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.
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