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The Division of Medical Oncology has an outstanding opportunity open for a Temporary Clinical Trials Start up Specialist.
The purpose of this position is to promote the research objectives of the Melanoma/RCC Program in the Division of Oncology. This position works with Division of Medical Oncology faculty to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials, identify research problems and design hypotheses to be tested. This position is responsible for independently designing and implementing multiple research projects to test the hypotheses in human subjects and facilitate laboratory correlative work.
This position is constantly required to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the U.S. Food and Drug Administration, the National Institutes of Health, and the study sponsor. This position develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Melanoma/RCC Program. 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 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 significant contributions to research development, implementation, and analysis for the Melanoma/RCC Program in the Division of Oncology. It is responsible for overseeing the management of up to 15 clinical trials, the majority of which provide significant financial support for the Division of Oncology. In the Melanoma/RCC group, this translates into $1.5 million dollars.
This position will be responsible for clinical research budgeting and revenue cycle strategy. Specifically, this position will initiate and negotiate optimal pricing and payment terms with industry sponsors, and ensure regulatory compliance and fiscal accountability for industry-sponsored clinical trials. This position will be responsible for up to 8 research projects at any given time and may be in various stages of development and/or negotiation. This position requires excellent skills, knowledge, and experience in clinical research coordination, revenue cycle development, budgeting, compliance, and regulations. This position reports to the MEL/RCC Program Manager and works closely with the MEL/RCC Program staff and faculty.
Scope of Responsibility: This position works with minimal supervision in performing work assignments. Works closely with the Melanoma and RCC Program Manager, Budgeting Team, and Faculty in making judgments and decisions within guidelines of UW and sponsor agency policies.
Manage clinical trials start up and amendments- (100%)
•Perform comprehensive and independent review of all documents and information related to the research study funding, including study budget, protocol, consent form, contract, and other supporting documentation. •Exercise independent judgment and discretion in interpreting complex oncology clinical trial protocols to develop study-specific budgets that account for all procedural and resource costs. •Initiate new studies or study amendments following institutional processes and intake systems •Independently negotiate successful clinical trial budgets and payment terms with study sponsors. •Assess and analyze opportunities and collaborate with manager to enhance the clinical research revenue cycle process by eliminating bottlenecks, streamlining processes, and improving efficiencies. •Provide effective strategic, intellectual, and technical assistance to faculty and staff on clinical research revenue cycle policies, and compliance. •Interpret, analyze, and implement all institutional, state, and federal policies related to clinical research fiscal cycle administration including Medicare Clinical Trials Policy and Medicare Secondary Payer Rule. •Partner with Program Managers and Faculty to strengthen clinical research revenue cycle operations, ensuring smooth functioning with a goal of standardized, efficient, and compliant budget development. •Coordinate with research staff to ensure each study’s consent form delineates research care and standard of care. •Coordinate and communicate with UW and SCCA offices involved in the review and negotiation of clinical trial budgets and contracts, including UW Clinical Research Budget and Billing office, the UW Office of Sponsored Programs, and the Seattle Cancer Care Alliance Research Implementation Office.
Required: Bachelor's Degree in Business, Accounting or Health-related field
• Minimum of two years’ experience with budget development, clinical research coordination, or related project management or health care experience • Exceptional organizational and customer service skills • Strong written and oral presentation skills • Ability to prioritize and organize work independently
Desired: • Experience in an academic medical center • Experience in oncology clinical research
Working Conditions: Fast-paced office environment, with a high volume of often-complex projects. The work is deadline driven and requires using a computer and telephone for the majority of the day remotely. Work week regularly exceeds 40 hours per week.
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.
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.
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“Onsite work” in the interim will vary for units and for specific positions and will be discussed with candidates during the interview process.
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