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 major activity of the Division of Hematology is research. Building on the distinguished accomplishments of the Division's founding members and early leaders, our current faculty continues to work at the cutting edge of molecular and cellular biology, pathophysiology, and applied clinical research. This work is carried out both as investigator-initiated projects within the Division and through collaborative efforts with colleagues at the Fred Hutchinson Cancer Research Center, basic science departments at the University, the Division of Oncology, and other Divisions in the Department of Medicine.
The Division of Hematology has an outstanding opportunity for a full-time Research Coordinator. The purpose of this position is to promote the research objectives of the Division of Hematology. This position works with Division of Hematology faculty to facilitate investigator-initiated and industry-sponsored clinical trials.
This position is 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, study sponsor and our affiliates. This position develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Division of Hematology. 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 federal and state agencies, foundations, pharmaceutical companies, health care providers and cancer patients in a manner that well-represents the University of Washington and its associated institutions (FHCRC and SCCA).
Must be able to work independently on multiple research projects; at times, without the benefit of written policies or procedures, while concurrently helping to create best practices moving forward. This position requires daily interaction with 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.
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.
Timely and appropriate reporting of Adverse Events and Serious Adverse Events to sponsors and review boards to ensure compliance to protocol and FDA requirements.
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 Research Implementation Office, and UWMC General Clinical Research Center) to ensure timely implementation of each research project.
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 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.
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.
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 UWMC for Hematologic clinical trials.
Analysis and Reporting
Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion.
Prompt completion of electronic data capture systems and electronic case report forms. Timely resolution of queries and questions from industry sponsors, contract research organizations, institutional groups and our affiliates.
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 general training.
Other duties as assigned
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 AND Two years of relevant work experience.
Excellent written and verbal communication skills, experience with Microsoft Office.
Previous experience working with both inpatient and outpatient research setting.
Previous experience with database development.
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.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Applicants should be highly motivated and energetic and while remaining personable, professional and organized under potentially stressful situations.
Previous experience developing and negotiating clinical research budgets.
Previous experience working with oncology patients.
Previous experience in clinical research project coordination; knowledge of FDA 21 CFR 50, and HHS 45 CFR 46 regulations, HIPAA, ICH Guidelines, and Good Clinical Practice; as well as, experience in clinical trial development, implementation, and analysis.
CONDITION OF EMPLOYMENT:
Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check.
This position requires a flexible work schedule. Stringent deadlines from sponsors and faculty 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.
Must be available to enroll patients and maintain email/pager contact with 24/7 availability. Some evening and weekend overtime may be required due to Adverse Event reporting requirements and study sample acquisition.
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.