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The University of Washington's Division of Medical Oncology includes 41 faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Research Center, the Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System. Over the past 25 years, members of the Division have developed the world's leading bone marrow transplant program. In addition, members of the Division have made substantial contributions to many other areas of cancer treatment, including the use of tumor vaccines, cellular therapy for cancer, antibody-based treatments, and novel forms of chemotherapy and hormonal therapy. Our Division is deeply committed to maintaining its position as one of the leading centers for research and treatment of cancer in the world.
The Division of Medical Oncology has an outstanding opportunity for a full-time Clinical Research Coordinator. The purpose of this position is to promote the research objectives of UW Hematologic Malignancies Research Program in the Division of Medical Oncology. This position works with faculty and staff 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 required to use independent judgment, leadership and expert knowledge of the academic clinical trial healthcare operations to effectively facilitate the work flow and promote a collaborative work environment. The position will maintain dynamic communication with the study investigators, research staff, numerous UW, SCCA, and FHCRC departments, federal agencies and industry partners.
This position is supervised by and reports to the Research Program Manager of the UW Hematologic Malignancies team. This position is constantly required 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. This position develops and implements procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Hematologic Malignancies team. 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 compliance for clinical trials and research studies for the UW Hematologic Malignancies Research Program in the Division of Medical Oncology. This individual will be responsible for overseeing the management of up to 15 clinical trials, the majority of which provide significant financial support for the Division of Medical Oncology. 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, Patient, and Data Management – 80 % •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 (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. •Design, create, revise, and complete 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. •May process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations. •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. •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 patients' clinical providers. •Initiate and maintain communication with outside physicians who refer patients to SCCA and/or UWMC for oncology clinical trials.
Protocol Development – 15 % •Assist in developing clinical research protocols that clearly describe the research objectives and procedures necessary to test the hypotheses of the research project. •May assist in writing informed consent documents that clearly describe the nature and risks of the research project in language that is easily understandable to the individual patient. •May 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.
Analysis and Reporting – 5% •Prepare interim reports for the research program and sponsors to ensure that each project is moving toward timely completion. •May perform other duties as assigned. The needs of the Research Program and clinical trial/research portfolio will inform primary allocation of above tasks.
REQUIREMENTS: •Bachelor's Degree in life or social sciences or related field. •A minimum of 2 years clinical research project coordination experience or equivalent. Sound knowledge of FDA, GCP, and NIH requirements relating to research involving human subjects. Experience using electronic data capture software. •Strong computer skills and competency with Microsoft Office software. Strong attention to detail and ability to multi-task, organize and prioritize multiple projects. Experience in clinical trial processes, implementation of research protocols. Excellent written and verbal communication skills. •Demonstrated ability to work independently, under supervision, and be a team player. Should be highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects. Maintain positive vision, sense of humor, and professional demeanor under potentially stressful situations. •Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete this training.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
DESIRED EXPERIENCE •Oncology clinical trial coordination experience. •Knowledge of University of Washington/Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance processes.
Conditions of Employment: •Ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. •May have to respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities. •Work hours frequently exceed 40 hours per week and may be deadline dependent. There may be deadlines over which an individual has no control that require a flexible schedule in order to accommodate, such as patient coordination needs, study sponsor deadlines, research program needs, grant deadlines, and faculty needs. •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. •Occasional evening and weekend work (e.g. to meet deadlines; potential travel to study meetings) may be required.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
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.
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.