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 includes 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 purpose of this position is to promote the research objectives of the Breast Cancer Research Program (BCRP). This position works with the BCRP Research Manager and Research Nurse Supervisor, faculty, other research staff and clinical staff to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials. This position is responsible for the implementation and coordination of assigned research studies using Good Clinical Practices to test research hypotheses in human subjects and for the facilitation of laboratory correlative science work.The Division of Oncology is physically located in the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center campus. This position requires operational knowledge of the University of Washington, Fred Hutchinson Cancer Research Center, and Seattle Cancer Care Alliance.A key mission of the BCRP is the conduct of basic, clinical, and translational Breast Cancer research. At any given time, multiple clinical treatment trials are actively accruing at the Seattle Cancer Care Alliance (SCCA) and the University of Washington Medical Center (UWMC). Under the direction of the Breast Cancer Oncology Director and Research Manager, this individual provides professional level support for clinical research studies involving human subjects.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.RESPONSIBILITIES:Protocol Management Independently develop and 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).Design, 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. case report forms) as necessary to ensure quality data that satisfies research objectives.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.Ensure that projects are executed successfully and completed within required time frames to meet research objectives.Patient Management Implement research protocols at SCCA and UWMC, integrating research and clinical requirements to ensure patient safety and protocol compliance. Communicate research requirements effectively with all providers involved in patient care.Manage complex patient schedules. 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.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.Data ManagementRetrieves 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.Protocol Development Assist in developing clinical research protocols that clearly describe the research objectives and procedures necessary to test the hypotheses of the research project. 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, and SCCA Clinical Trials Planning Committee) to ensure timely implementation of each research projectAnalysis and Reporting Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion.OtherPromotes 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.Assists in the orientation and mentoring of new and existing staff in the Program.Works with Manager and fellow team members to insure adequate staffing levels for Program, including helping to cover sick call, vacations, etc.Additional duties as deemed qualified.REQUIREMENTS:2 or more years experience and Bachelor's Degree in Biology or health related field.Experience in coordinating NIH sponsored or industry sponsored clinical research coordinationADDITIONAL REQUIREMENTS:Knowledge of Oncology practice and terminologyDemonstrated ability to examine documents for accuracy and completenessDemonstrated ability to work independentlyKnowledge of FDA and NIH/CTEP requirements relating to research involving human subjectsUnderstanding of ethical & legal liability, and patient safety issues associated with non-compliance with regulations governing researchGood communication skills and a proven track record of working successfully within a team, with patients, other businesses, and with the publicAbility to speak clearly and concisely, and to communicate effectivelyAbility to maintain positive vision, sense of humor and flexibilityAbility to multi-task and adapt quickly to changes in team priorities, maintaining a professional demeanor at all timesAttention to detail Prior experience with complex data entry systems (such as Medidata, InForm, TAOS, DataTrak, Velos, etc.)Competency in Microsoft Office softwareDESIRED:Previous experience working with oncology patientsKnowledge of University of Washington/Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance regulatory processes. Completion of Good Clinical Practice coursePrior experience working at the University of Washington or Fred Hutchinson Cancer Research CenterApplication 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
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.