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Department of Medicine: Oncology has an outstanding opportunity for a Senior Data Coordinator.

Position Purpose:

The University of Washington, Division of Medical Oncology has an excellent position for a Senior Research Data Coordinator in the Gastrointestinal Oncology Research Program.

The purpose of this position is to promote the research objectives of the GI Oncology Research Program in the Division of Oncology. This position works with Division of Medical Oncology faculty to facilitate pharmaceutical-sponsored and investigator-initiated clinical trials, identify research problems and design hypotheses to be tested. This position will be responsible for assisting the Research Program Manager with training junior Data Coordinators, assisting with the hiring of new Data Coordinators, and to assist with the oversight of all program protocol and data management.

Position Complexities:

This position 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 designing and implementing tools to improve the GI Oncology Research Program clinical trial processes.

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.

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 the Research Program Manager, research staff, physicians, other health care personnel (e.g. nurses, mid-levels), research staff at collaborating institutions, pharmaceutical company sponsors and any other groups integral to the successful completion of research projects.

Data Management, Integrity and Compliance Oversight - 60%

•Oversee the data integrity of the GI Oncology Research Program clinical trials. Understand multiple commercial electronic data capture systems and ensure timely and accurate entry of complex clinical information.
•Independently 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.
•Work with study team members 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).
•Responsible for maintaining computer spreadsheets and databases for research studies.
•With study team, draft scheduling request orders and worksheets to meet study protocol and EDC needs.
•Work professionally with sponsor representatives to review and correct data recorded in the case report forms.  Resolve queries in conjunction with research coordinators.     
•Request medical records from outside medical facilities.
•Work with the GI Oncology Research Program Manager to develop process improvement tools. Assist in the assessment and design of tracking tools with the manager to develop standard practices within the GI Oncology Research Program.
•Clinical Trial Management System (CTMS) Data Entry.
•Provide input in design and implementation of research tools for investigator-initiated trials.
•Develop and maintain data standard operating procedures and workflows for the Program. Interpret, implement, and verify compliance with applicable federal and institutional SOPs.
•Develop procedures for data quality control to ensure completeness and accuracy of data.

Systems Design and Maintenance - 35%

•Design tools for the GI Oncology Research team to refine and improve clinical trial implementation processes.
•Design and building case report forms (CRFs) for investigator-initiated trials. Create and maintain study specific CRF guidelines.
•This position will be the primary resource for design and maintenance of electronic databases and online platforms for the GI Oncology Research Program.
•Maintain organization and documentation of systems used by the GI Oncology Research Program.
•In collaboration with the Research Program Manager, participate in process improvement plans. Help maintain program metrics for process improvement.
•Train other team members to use program tools and systems.
•Provide technical updates for other team members.
•Create and maintain training documents related to systems used within the Malignancies Research Program.

Other Program Support - 5%

•Assist the Research Program Manager with the hiring, training, and onboarding of new Data Coordinators.
•Working with the Research Program Manager, assist with oversight of Data Coordinators and completion of Annual Performance Evaluations.
•Assist investigators and study team with preparation and analysis of study data for publication, grant preparation, and FDA submissions.
•Assist Faculty and Research Program Manager with clinical informatics projects and presentations as needed.
•Participate in institutional trainings related to systems on behalf of the GI Oncology Research Program.
•Perform other tasks as assigned.

Lead Responsibilities:

•Assist with hiring, training and onboarding of new Data Coordinators
•Assist with oversight of Data Coordinators and writing evaluations



MINIMUM REQUIREMENTS:

•Bachelor's Degree in Biology or Health-related field
•Two years of experience

Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

ADDITIONAL REQUIREMENTS:

•Demonstrated understanding of medical terminology
•Strong computer skills and experience with data entry and databases
•Strong attention to detail
•Strong organizational skills and an ability to prioritize multiple projects
•Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues and study sponsor representatives
•Knowledge of Oncology practice and terminology
•Prior working experience with common eCRF systems (e.g. InForm, Medidata, REDCap, etc.)
•Competency in Microsoft Office software and Access
•Knowledge of HIPAA regulations
•Knowledge of GCP (Good Clinical Practice)


WORKING CONDITIONS:

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 may exceed 40 hours per week and can be deadline dependent.


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.