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The purpose of this position is to promote the research objectives of the GI program in the Division of Oncology. This position works with Division of Medical Oncology faculty, Research Manager and other research and clinical staff to facilitate GI pharmaceutical-sponsored and investigator-initiated clinical trials. This position is responsible for independently implementing and coordinating multiple research projects using Good Clinical Practice to test research hypotheses in human subjects.

This position is constantly required to integrate information from multiple sources to ensure that all research projects are conducted according to GCP, the research protocol and regulatory requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor.  This position works closely with clinic staff to ensure all protocol procedures are completed as required, including pharmacy, infusion, clinic and radiology staff as well as ensuring data collected is accurate. The Research Coordinator ensures patient safety. 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 significant contributions to research development, implementation and analysis for the GI Program in the Division of Oncology.  It is responsible for overseeing the management of clinical trials, the majority of which provide significant financial support for the GI program.  Furthermore, at any one time up to 30 oncology patients from the various GI trials 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 pharmaceutical sponsors, physicians, the U.S. Food and Drug Administration, 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 -- 50%
Independently develop and implement research project policies and procedures that meet research objectives that ensure compliance with all aspects of 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).

Design, develop, document and maintain policies and procedures for protocol registration and implementation to ensure that research execution meets good clinical practice guidelines.

Complete, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives.

Design, document and implement procedures for protocol audits to assure protocol compliance and to ensure research data quality.

Take action to correct problems such as deviation from protocol requirements to ensure research quality.

Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.

Coordinate, track and ensure shipment of specimens in accordance with federal and institutional biologics shipping regulations.

Patient Management - 30%
Ensure protocol compliance by managing patient appointments and coordinating with patient’s clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.

Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patient’s clinical providers.

Initiate and maintain communication with outside physicians who refer patients to SCCA and/or UWMC for GI 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.

Data Management: 10%
Retrieve data from patient charts and/or source documents, abstract information from complex medical records and reports into Sponsor created case report forms. Case report forms may be paper or electronic. CRF completion and data entry responsibility may be shared with research team members, ensuring accurate and timely reporting of study data.

Analysis 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 with clinical research involving human subjects within UW Medicine; therefore clinical Research Study Coordinator (RSC) training is required.  The training requirement for this position includes UW Medicine-specific as well as general training.

MINIMUM QUALIFICATIONS:
Bachelor's Degree in a health-related field (equivalent experience can substitute for education).

A minimum of 2 years of experience in clinical, pharmacy or laboratory research project coordination, clinical experience, knowledge of FDA and NIH requirements relating to research involving human subjects, knowledge of oncology practice and terminology, attention to detail, demonstrated ability to adhere to complex protocols and standard operating procedures, excellent communication skills and a proven record of working successfully with multiple stakeholders, thrive in a fast-paced clinical research program.

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.

DESIRED:
Previous experience working with oncology patients, CCRC or CCRP endorsement.

WORKING ENVIRONMENTAL CONDITIONS:
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, as well as 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 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.