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The Clinical Trials Office (CTO) is a central clinical research operation with compliance responsibilities and services across the vast portfolio of clinical trials at UW Medicine. The CTO operation has direct impact on UW reputation with major global biotech and biopharma sponsors and the availability of funded clinical trial opportunities in UW pipeline. In addition, the CTO plays a key role in mitigating institutional financial and reputational risks by ensuring strict compliance with the CMS and the FDA regulations and guidelines. Clinical Research Budget Specialist is a key position to maintain secure and fully compliant clinical research operation across the UW Medicine.
The Clinical Trials Office has an outstanding opportunity for a Clinical Research Budget Specialist.
The Clinical Research Budget Specialist will focus primarily on the billing compliance and budgetary review of clinical trials in start-up at UW and Fred Hutch Cancer Center, as well as the review of clinical trial amendments. This work is performed within the Clinical Research Budget and Billing (CRBB) unit of the CTO. Aside from the CRBB compliance and budgetary review, the incumbent will support the work within other CTO finance areas of responsibility, including creation of billing grids and budgets for clinical research studies that include clinical services, items, and/or tests provided by UW Medicine facilities and/or members of UW Physicians (UWP). The successful candidate will perform financial compliance review, coverage analysis and creation of study billing grids, assist study teams and investigators with budget development and negotiation with sponsors, and collaborate on process improvements benefiting internal operations and study team services. Attention to detail, efficiency, and a strong team orientation are essential to this position.
Regulations governing hospital billing for research costs are complex and critical to UW Medicine’s compliance with federal regulations. The responsibilities of this role require rigorous analytical ability and knowledge of medical services across the full range of medical specialties in order to provide adequate review of billing compliance documents and support in preparation for clinical trial budget development and negotiation. Extensive Medicare regulations and clinical research operations knowledge is necessary to successfully perform assigned responsibilities. Attention to detail must be combined with efficient management of a portfolio of diverse clinical trial protocols.
DUTIES AND RESPONSIBILITIES
Clinical Research Budget and Billing Review, Coverage Analysis and Budget Development and Negotiation Support
As part of CRBB billing compliance related activities: • Understand and exercise independent judgment and discretion in the interpretation and application of the Medicare Clinical Trial Policy, and all relevant UW Medicine clinical research budgeting and billing policies and procedures. • Perform comprehensive and independent review of all documents related to research study funding, including the research study budget, protocol, contractual terms, informed consent and other supporting documentation. Ensure alignment of these documents with the billing grid and federal regulations. • Analyze, interpret and apply internal and external research billing policies, assisting faculty, study staff, and clinical managers in determining applicable review requirements and facilitating timely budget approval. • Provide excellent customer service and accurate guidance to study teams regarding clinical research budgeting and billing policies and procedures. Keep study teams apprised of project status. • Serve as backup for other functions on the CRBB finance team, e.g. intake, implementation, pricing, etc.
As part of the CTO fee-for-service activities: • Triage all incoming studies to identify the operational flow for coverage analysis and submit to third-party vendor for services when applicable. • Perform coverage analysis or review and validate coverage analysis performed by a third party vendor; interpret and apply Medicare coverage rules and designating study items and services as non-covered research-only or covered routine. • Review and finalize study billing grids, properly documenting coverage analysis decisions, or review and validate billing grids developed by a third party. • Advise investigators and study teams on applicable regulatory requirements pertaining to coverage analysis decisions. Escalate disputed coverage designations as needed in accordance with established escalation procedures. • Develop or assist with developing clinical trial budgets in preparation for negotiation of budgetary and payment terms with pharmaceutical and biotechnology corporate sponsors, contract research organizations and other sponsor institutions. • Negotiate clinical trial study budgets with industry sponsors.
Administrative • Regularly update and work with the CTO database, tri-institutional CTMS (OnCore), SCCA sRAMP and other comprehensive electronic study documentation for each clinical research study, in compliance with UW policies, procedures and standards. • Participate in internal and interdepartmental project teams within UW Medicine as assigned. • Assist in development of content for CTO and CRBB websites and outreach documents. • Perform other clinical research finance-related duties as required.
Education & Communication • Deliver on-going education to School of Medicine investigators, research staff and practice site staff on research budgeting and billing policies, procedures and tools. • Serve as a point of contact across multiple sites of practice and UW School of Medicine departments to disseminate information for clinical trial budgeting and billing. • Effectively collaborate with and communicate important information to external investigators and research teams at partner institutions, e.g. Fred Hutch CRC, SCCA, and Seattle Children’s. • Assist in the development of UW Medicine policies, standardized procedures and tools for clinical research pricing, budgeting and billing; assist in review of regulations to ensure ongoing compliance with federal and institutional policies. • Support UW Medicine hospitals and practice plan staff with implementing, maintaining and improving appropriate clinical research revenue cycle procedures.
MINIMUM REQUIREMENTS Bachelor's Degree in science, business, healthcare administration or related field. Minimum of three years of experience in clinical research finance field or clinical research study coordination/management, or other accounting/finance experience.
Additional Requirements: • Ability to convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience. • Strong working knowledge of Microsoft Excel, Access, and Share Point. • Ability to teach and mentor others in group settings, in one-on-one sessions, and remotely. • Ability to effectively organize work and prioritize projects and timelines in a multi-faceted, fast-paced environment. • Ability to work effectively and efficiently in a group environment. • Exceptional customer service skills. • Strong written and oral presentation skills. • Ability to communicate effectively with all levels of staff, faculty, management and site of practice staff. • Experience in academic health system operations or medical setting.
Equivalent education and/or experience may substitute for minimum requirements.
DESIRED REQUIREMENTS • Knowledge of the Medicare Clinical Trial 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. • Familiarity with electronic medical records and healthcare business systems. Experience working with web-based solutions
CONDITIONS OF EMPLOYMENT This position is primarily in an administrative office setting. Computer and phone use is frequent. Traveling to UWMC, HMC, and SCCA is necessary at times. Working beyond a normal workweek may be required.
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 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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