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Department of Medicine: Oncology has an outstanding opportunity for Research Coordinator.

The purpose of this position is to promote the research objectives of the Melanoma/RCC 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 independently designing and implementing multiple research projects to test the hypotheses in human subjects and facilitate laboratory correlative work.

This position is constantly required to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the U.S. Food and Drug Administration, the National Institutes of Health, and the study sponsor. This position develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Melanoma/RCC Program. 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 independently and in a resourceful manner to expedite the Division's research objectives. This position is also responsible for organizing 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 significant contributions to research development, implementation, and analysis for the Melanoma/RCC Program in the Division of Oncology. It is responsible for overseeing the management of up to 15 clinical trials, the majority of which provide significant financial support for the Division of Oncology. In the Melanoma/RCC group, this translates into $1.5 million dollars.

RESPONSIBILITIES:

This position must be able to work independently under administrative direction 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 15 projects will be in progress simultaneously, with the expectation of additional projects in the future.

Protocol Management – 30 %

Independently develop and implement research project policies and procedures that meet research objectives and 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 (ex: 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.

Design, create, complete, and revise research instruments, such as 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 deviations from protocol requirements to ensure research integrity.

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

Process labs for clinical trials, including collecting, centrifuging, and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations.

Analysis and Reporting – 30 %

Prepare interim reports for supervisory staff, principal investigators, industry sponsors, and the Institutional Review Board to ensure that each project is moving toward timely completion.

Patient Management - 30%

Ensure protocol compliance by managing patient appointments and coordinating with patient’s clinical providers (physicians, physician assistants, nurses, etc.) to collect reliable and accurate data.

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.

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 collaborate in the care of patients on UWMC/SCCA oncology clinical trials

Protocol Development – 10 %

Assist in developing clinical research protocols that clearly describe the research objectives and procedures necessary to test the hypotheses of the research project.

Write informed consent documents that clearly describe the nature and risks of the research project in language that is easily understandable to the individual patient.

Work with multiple UW, SCCA, and Fred Hutchinson Cancer Research Center (FHCRC) groups (e.g. UW Grant and Contract Services, UW Human Subjects Review Committee, UW and SCCA Radiation Safety Committee, UW and FHCRC Biosafety Committee, SCCA Clinical Trials Planning Committee, and UWMC General Clinical Research Center) to ensure timely implementation of each research project.

MINIMUM REQUIREMENTS:

Bachelor’s Degree in physical, life, or social sciences.

A minimum of 2 years experience in clinical research project coordinator, knowledge of FDA and NIH requirements relating to research involving human subjects, experience in clinical trial development, implementation, and analysis, excellent written and verbal communication skills, experience with Microsoft office, experience with case report forms (ideally paper and electronic).

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

ADDITIONAL REQUIREMENTS:

This position will work with clinical research involving human subjects within UW Medicine, and therefore Clinical Research Study Coordinator (CRSC) training is required. The training requirements for this position including UW medicine-specific, as well as general, training.

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 30 days of hire.

Applicants should be highly motivated and energetic and should be able to carry themselves in a personable, professional, and organized manner under potentially stressful situations. Applicant should have the ability to be flexible and adapt to change (e.g. new projects, shifting priorities, emergent deadlines) readily.

DESIRED:

B.S. In biology or health-related field.

A minimum of 2 years prior oncology clinical trial management experience.

Previous experience with Access and web-based data capture systems.

Certification from one of the professional clinical research organizations.

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.