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The Division of Medical Oncology in the Department of Medicine has an outstanding opportunity for a full-time Clinical Trials Start-Up Specialist (Research Coordinator).
This position is responsible for clinical trial budget development in the Gastrointestinal (GI) Medical Oncology program in the Division of Medical Oncology. This position will accelerate clinical trial study start up new and amended clinical trial protocols by developing budgets and forecasts, pre-review evaluations, and development of clinical trial portfolio including both investigator-initiated and Sponsored trials. This position will ensure adherence to start-up processes and procedures among various UW, SCCA and Fred Hutch departments, including the UW Clinical Trial Office, SCCA Clinical Operations Research Services and Fred Hutch Clinical Research Support and Clinical Trial Management System.
This position is required to use independent judgment, leadership and knowledge of the academic clinical trial business to effectively facilitate the workflow and promoting a collaborative work environment. The position will maintain dynamic communication with the study investigators, research staff, numerous University departments, SCCA departments, and the Fred Hutch departments, other development partners (other universities, federal, and industry partners). This position is supervised by and reports to the Gastrointestinal (GI) Oncology Research Manager.
This position is constantly required to integrate information from multiple sources to ensure that all study start-up proposals meet the requirements of the University and external agencies, institutions and industry. This position is required to coordinate efforts and provide information across the Alliance partners including UWMC, Fred Hutch, SCCA, and Harborview departments and staff.
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 coordination 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.
This position is key to the success of the Gastrointestinal (GI) Oncology Clinical Research Program and promotes timely study start-up oncology clinical trials. It will require a strong partnership with faculty and staff within and external to the programs.
Develop clinical trial budgets
Establish and maintain methods to initiate study start-up budget planning
Work with Lead Coordinator to develop and study budgets throughout the life cycle of the clinical trial including budget and contract amendments
Use knowledge of clinical research, medical terminology, and clinical processes to ensure clinical trial budget accurately reflects impact to UW, SCCA and Fred Hutch departments.
Identify protocol requirements that will impact clinical trial budgets.
Working with the Research Manager and faculty, establish methods to translate study start-up pricing and budget efforts into study tracking tools, to streamline the invoicing of sponsors based on patient accrual and visits
Clinical trial start-up processes
Assist with forecast, track and report study start-up timelines.
Develop and track study start-up pieces and report progress to Research Managers, faculty, and study team members.
Produce monthly and quarterly study start-up metric reports using established formats.
With minimal guidance, develop and implement research project procedures and tools 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). Communicate research requirements effectively with all providers involved in patient care.
Design, develop, document and maintain policies and procedures for 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. 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.
Perform 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 related field plus one year of related experience.
Experience with clinical research budget development, clinical research coordination, or related research or healthcare experience
Ability to work effectively and efficiently in a group environment
Exceptional organizational and customer service skills
Strong written and oral presentation skills
Ability to communicate effectively with all levels of faculty, management and clinical research staff
Thorough knowledge and ability to convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience
Ability to teach and mentor others in group settings, in one-on-one sessions, and remotely
Ability to prioritize and organize work independently
Demonstrated skill in using Microsoft Excel
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Experience in an academic medical center
Experience as a research study coordinator
Experience in oncology clinical research
Familiarity with interpreting regulatory and contractual documents, identifying and resolving ambiguities, negotiating pricing and payment terms, and interpreting complex implications of research protocols
Knowledge of the Medicare Clinical Trials Policy and other federal, state and institutional clinical research regulations
Experience with using International Classification of Diseases, 10th Revision (ICD-10), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) billing codes in a clinical research environment
Strong working knowledge of Microsoft Office Suite
CONDITIONS OF EMPLOYMENT
Fast-paced office environment, with a high volume of often-complex projects. The work is deadline driven and requires rapid and frequent communications, not only between individuals, but also by computer and/or telephone for much of the day. Projects may require travel between affiliate locations to facilitate budgeting communication.
The 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.
This position requires a flexible work schedule. Stringent deadlines from sponsor organizations/companies to meet deadlines may require overtime including occasional evening and weekend overtime.
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.
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