The University of Washington (UW) is proud to be one of the nation’s premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research, and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty.
At the University of Washington, diversity is integral to excellence. We value and honor diverse experiences and perspectives, strive to create welcoming and respectful learning environments, and promote access, opportunity and justice for all.
UW's Department of Medical Oncology has an outstanding opportunity open for a Temporary Research Data Coordinator.
The purpose of this position Research Data Coordinator is to promote the research objectives of the Breast Cancer 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 the ability 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. 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.
Protocol Management – 40%
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.
Work with Data Coordinator and Research Manager to design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives. Assist data coordinators to resolve data queries. Provide source documentation to data coordinator in a timely manner.
Work with Regulatory Coordinator to ensure that reporting to the Institutional Review Board 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.
Understanding research study flow, work with clinic staff, support services and research team members as needed to implement clinical trials.
Patient Management - 25%
Advise clinical staff which tests and procedures are needed during each research visit to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection. Work closely with clinical providers to ensure that study therapy is administered in accordance with the clinical protocol (e.g. dose modifications are implemented when required by the protocol).
Communicate with outside physicians who are interested in referring patients to UWMC/SCCA for oncology clinical trials.
Understand clinical trial budget and billing plan for patients enrolled on clinical trials. Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance. Assist in financial audits as necessary. Communicate with investigators and research staff when financial milestones have been met.
Assist with retrieval and return of oral investigational agents to the Investigational Drug Pharmacy.
Obtain medical records from external providers and facilities.
Collate and maintain clinical information from multiple sources into research charts, study binders, etc. To include redacting and scanning of clinical documents and maintenance of electronic files.
Research Support - 25%
Maintain and update clinical trial resources and reference materials, including physician workroom binders. Courier research samples from Clinical Trials Unit or Blood Draw to Research Specimen Processing Lab.
Independently complete laboratory requisition forms and assemble specific lab kits for upcoming research subject visits.
Independently request, track, and ship research subject blood, urine, tissue samples and radiology scan copies from both internal and external providers. Follow study specific guidelines for collection, labeling, and/or shipping.
Archive old research documentation and maintain log of archived materials. Responsible for maintaining computer spreadsheets and databases for research studies.
Analysis, Data Management, and Reporting – 10 %
Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion.
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.
Assist with data entry into Sponsor based electronic case report form systems.
Bachelor's Degree in life sciences
A minimum of 1 year experience, experience in research setting or 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.
Previous experience working with oncology patients. Previous experience conducting research in a hospital or academic setting.
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.
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.