Req #: 183766 Department: ONCOLOGY Posting Date: 10/20/2020 Closing Info: Open Until Filled Salary: Salary is commensurate with experience and education Shift: First Shift Notes: The University of Washington is following physical distancing directives from state and local governments as part of the collective effort to combat the spread of COVID-19. Click here for updates "Onsite work" in the interim will vary for units and for specific positions and will be discussed with candidates during the interview process. As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem solving skills and dedication to build stronger minds and a healthier world. UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty. All of which has allowed the UW to be nationally recognized as a "Great College to Work For" for six consecutive years. The Division of Medical Oncology in the Department of Medicine has an outstanding opportunity for a full-time Clinical Trials Specialist. This position is the Phase 1 Clinical Trials Specialist responsible for clinical research trial budgeting and revenue cycle strategy, development and oversight for the Phase 1 Program in Division of Medical Oncology. Specifically, this position negotiates optimal pricing and payment terms with industry sponsors and ensures regulatory compliance and fiscal accountability for industry-sponsored clinical trials. At any given time, up to 15 clinical trial projects 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 Phase 1 Finance Manager and works closely with the Phase 1 Program research staff and faculty leadership. Position Complexities: Medical Oncology is a Division within the Department of Medicine. The Division has as its primary mission, to improve cancer care by moving discoveries made in the laboratory to a clinical setting and finding new and innovative ways to use existing therapies. Our vision is to be a national leader in oncology translational medicine. The Division of Medical Oncology is primarily located in the Seattle Cancer Care Alliance (SCCA), on the Fred Hutchinson Cancer Research Center campus, but also has faculty and staff located at University of Washington (UW) Medical Center, Harborview Medical Center, the VA Puget Sound Health Care System, and South Lake Union. This position interacts closely with multiple process partners, including SCCA, UW and FHCRC clinical and administrative departments and multiple regulatory committees. The Phase 1 Program has an annual operating budget of $8 million, 1 faculty and 35 research and administrative staff. At any given time the Phase 1 Program has over 30 open studies with over 70 enrollees, which generates critical research funding and discovery mechanisms as well as to bring much-needed investigational treatments to oncology patients with few or no other options. Duties & Responsibilities: This position is responsible for ensuring financial accountability and regulatory compliance for the Phase 1 Program. The Phase 1 Clinical Trials Specialist manages revenue cycle through grant/contract-specific strategic development of coding and billing infrastructure, compliance assessment and operations. Budget Development and Financial Management + Manage study start-ups and implementations for Phase 1 Program by working closely with Regulatory and Research Teams and institutional stakeholders (UW CRBB, UW CTO, CTMS, SCCA CRBO, SCCA CORS and UW OSP) as the main point of contact in communication with sponsors and CROs. + 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. + Interpret, analyze and implement all institutional, state and federal policies related to clinical research financial administration including Medicare Clinical Trials Policy and Medicare Secondary Payer Rule; act as Division expert on such polices. + Coordinate with research staff to ensure each study's consent form delineates research care and standard of care. + 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. + 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. + Independently negotiate successful clinical trial budgets and payment terms with study sponsors. + Ensure all regulatory and contractual documents are appropriately reflected and ambiguities are recognized and addressed. + Work with UW OSP to execute clinical trial agreements. + Attend study implementation meetings. Operations and Strategic Planning + Assess and analyze opportunities to enhance 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, compliance, and regulatory matters. + Assist with on-going education on research budgeting and billing policies, regulations and compliance matters. + Collaborate in the development of clinical research revenue cycle policies. Monitor and assess program compliance around clinical trial budget development, identifying opportunities for improvement and implementing changes to stabilize and strengthen compliance. + Participate in Program and Institutional meetings as needed. + Work with the Finance Manager to improve study start-up timelines. + Other duties/projects as assigned by Finance Manager. Lead Responsibilities: + Phase 1 Program expert on clinical trial budgeting and revenue cycle development, policies, and compliance. As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here. REQUIREMENTS: + Bachelor's Degree in Business, science, or health-related field plus a minimum four years' experience with clinical research budget development, clinical research coordination, or related research or healthcare experience. Additional Requirements: + 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. + 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. DESIRED + 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, 9th Revision (ICD-9), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) billing codes in a clinical research environment. + Strong working knowledge 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. Work week regularly exceeds 40 hours per week. + 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. University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.