Salary is commensurate with experience and education
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.
The University of Washington's Division of Medical Oncology's 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 Research Coordinator. This individual will promote the research objectives of the Breast Oncology Program in the Division. This position works with faculty to facilitate investigator-initiated, cooperative group and pharmaceutical- sponsored clinical trials.
A key mission of the Breast Cancer Research Program (BCRP) is the conduct of basic, clinical, and translational Breast Oncology research. At any given time, multiple clinical treatment trials are actively accruing at the SCCA. Under the direction of the Research Manager and the faculty, this individual provides professional level support for clinical research studies involving 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.
Independently 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).
Work with multiple UW, SCCA, and Fred Hutchinson Cancer Research Center (FHCRC) groups (e.g. UW Grants and Contract services, UW Human Subjects Review Committee, CRS, SCCA and UW Radiation Safety Committee, etc.) to ensure timely implementation of research projects.
Develop, document and maintain policies and procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
Design, create and revise research instruments (e.g. study specific worksheets) as necessary to ensure quality data that satisfies research objectives.
Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality.
Develop and implement corrective action plans to ensure protocol adherence and data integrity.
Implement research protocols in the SCCA clinic, integrating research and clinical requirements to ensure patient safety and protocol compliance.
Communicate research requirements effectively with all providers involved in patient care. Together with principle investigators and treating physicians, serve as the point person and team leader for assigned research projects.
Ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Align research requirements and clinical care to ensure collection of accurate and reliable data.
Communicate with outside physicians who are interested in referring patients to UWMC/SCCA for clinical trials.
This position requires daily interaction with patients, treating physicians, Advanced Practice Providers, investigators, clinic staff, pharmaceutical sponsor representatives, the U.S. Food and Drug Administration, and other health care personnel (e.g. nurses, patient care coordinators, insurance companies, etc.). Approximately 5-10 projects will be in progress simultaneously, with the expectation of additional projects opening or closing in the future.
Assist with consenting, and oversee screening, and enrollment of patients to assure appropriate patient selection according to specific protocol inclusion and exclusion criteria.
Retrieves data from patient charts and/or source documents, abstracts information from complex medical records and reports for entry into sponsor provided case report forms. Case report form may be paper based or electronic. CRF completion and data entry responsibility may be shared with other team members, necessitating accurate and timely communication with all team members.
Prepares source data documents to collect/support all data associated with research protocols.
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.
Promotes a proactive and professional relationship with internal and external staff and affiliates.
Maintains strictest confidentiality.
Actively participates in meetings and/or training as required.
Serves as subject matter and protocol expert for assigned studies.
Works with Manager and fellow team members to insure adequate staffing levels for Program, including helping to cover sick call, vacations, etc.
Responsible for maintaining computer spreadsheets and databases for research studies.
Understand research study flow, work with clinic staff, support services and research team as needed to implement clinical trials.
Assist with audits as necessary.
This position will work with clinical research involving human subjects within UW Medicine and therefore clinical Research Study Coordinator (RSC) training is required. The training requirement for this position includes UW Medicine-specific as well as Fred Hutchinson-specific and general training.
Collaborate with internal and external partners. Maintain direct communication with faculty members, UW departments, and research collaborators in support of the overall research plan.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor's Degree in Science or Health-related field plus a minimum of 2 years experience in an academic research environment, clinical, pharmacy or laboratory research project coordination.
Prior experience as a research coordinator.
Knowledge of FDA and NIH requirements relating to research involving human subjects and clinical trial implementation and analysis.
Excellent written and verbal communication skills.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Prior experience working in an oncology setting. GCP training and/or Research Certification.
Experience with Microsoft Office and Adobe Acrobat.
Able to work independently and be a team player; to maintain positive vision, sense of humor, and flexibility; to multi-task and as priorities change, maintaining a professional demeanor at all times.
CONDITION OF EMPLOYMENT:
Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check.
Sitting at desk for majority of hours worked; working on a computer and on the telephone in a cubicle in a public area with little privacy. Ability to multi-task and be flexible is crucial as priorities change throughout each day. May have to respond to multiple requests for information (email, voicemail, fax, verbal), determining priorities.
There may be externally imposed deadlines over which individual has no control that require a flexible schedule in order to accommodate, such as study sponsors', 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. Work hours frequently 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 Workforce Authorization, Criminal Conviction History, 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 undergra...duate 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.