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The Clinical Trials Office (CTO) supports the clinical research mission of UW Medicine. The CTO is an operational unit within the SOM’s Office of Research and Graduate Education charged with providing multi-service support to clinical researchers bringing important new therapies to our patients in compliance with evolving regulatory requirements.
The Clinical Trials Office has an outstanding opportunity for a part-time (60% FTE) Research Coordinator to support the operations and administration of the Center.
The CTO provides support and education to help investigators improve the quality of their research and ensure compliance with federal, state, and institutional regulations. The CTO Research Coordination Center (RCC) provides support to clinical researchers from the six health sciences schools and others across our partner institutions. The RCC provides assistance with investigator-initiated biomedical or behavioral studies as well as pharmaceutical sponsored clinical trials. The RCC is designed to provide assistance to investigators with their research projects by assisting with the IRB approval process and the design and implementation of investigator initiated and industry-sponsored research protocols.
This Research Coordinator position works integrally with the Human Subjects Division, Clinical Budgeting and Billing, the Office of Sponsored Projects, and other research support departments such as Investigational Drug Services and the Translational Research Unit within the University. It also interfaces with like positions at Seattle Children's Hospital and Fred Hutchinson Cancer Research Center to create consistent and smooth processes and procedures. This position provides the opportunity to improve the efficiency and compliance of clinical research programs throughout the institutions.
The Research Coordinator interacts with numerous staff, patients, study participants, and faculty. The person in this role must exhibit an appreciation of, a sensitivity to, and respect for a diverse academic and clinical environment, inclusive of patients, faculty, and staff of many social, economic, cultural, ideological, racial and ethnic backgrounds. The position requires a high degree of flexibility and the ability to work in a variety of settings and locations. The Research Coordinator may work on 4-8 projects simultaneously depending on the complexity of the assignments.
Research Operations Support (65%): • Assist investigators and research teams with the start-up and implementation of clinical studies, including obtaining and submitting budget/billing information, implementing the IRB-approved recruitment plan, interacting with research participants, scheduling study visits, gathering data, processing specimens, presenting information to the research team, etc. • Design, create, and revise research instruments as necessary to ensure quality data that correlates with research objectives; coordinate multiple protocol-specific data collection efforts for one or more research projects which may include other collaborating agencies or institutions. • Consult with investigators on appropriate management of participant problems and concerns; troubleshoot acute individual or departmental research issues.
Regulatory Support (25%): • Obtain and maintain IRB approval for investigators (create and submit IRB applications for minimal risk, standard studies, medical record review, repositories, etc.) from the UW IRB, FHCRC IRB, Western IRB, VAPSHCS IRB, Seattle Children's IRB, and other IRB's as required. • Oversee regulatory, budgetary, contractual, and all other aspects of protocol implementation, ensuring compliance with applicable federal regulations, institutional policies, and the principles of Good Clinical Practice (GCP).
Fiscal Support (10%): • Consult with faculty to determine accurate cost projections for industry and federally funded research protocols. • Create budgets for industry studies through CRBB and budget projections for federally sponsored protocols.
Other duties and training as required.
MINIMUM REQUIREMENTS • Bachelor's degree in a biological science or health related field and three years experience as a research professional for investigator-initiated research projects, with expertise in grant and protocol management including oversight of daily research operations.
Additional requirements: • Excellent written and verbal communication, including patient interactions, consulting, and customer service skills. • Proficiency with standard MS Office software, including Word, Excel, Access, and Power Point. • Strong internal and external customer service skills. • Ability to adapt and respond appropriately to competing priorities in a fast-paced environment. • Self-motivated, self-starter who takes initiative to improve existing processes.
Equivalent education and/or experience may substitute for minimum requirements.
DESIRED REQUIREMENTS • Certified as a Medical Assistant in the State of Washington. • Fluency in a language other than English. • Experience with community engagement • Experience in clinical research ethics and/or human subjects protection. • Experience with project management or CPI training.
CONDITIONS OF EMPLOYMENT 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.
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.