POSITION RESPONSIBILITIES

Coverage Analysis, Clinical Trial Budget Analysis and Negotiation:
• Perform comprehensive and independent analysis of clinical trial protocols and other study documents, including the research study budget, contract, informed consent, pharmacy and lab manuals, and other supporting documentation.
• Perform detailed coverage analysis of research procedures in alignment with CMS rules and develop audit-ready study billing grids.
• Assist investigators in determining study status under Medicare coverage rules and in identifying services as non-covered research-only, routine care, investigational items and services along with their associated costs.
• Understand and exercise independent judgment and discretion in the analysis, interpretation and application of the Medicare National Coverage Decisions (NCD) and Noridian local coverage decisions (LCD) for routine costs in clinical trials, and all relevant UW Medicine clinical research budgeting and billing policies and procedures.
• Analyze industry sponsor budget proposal, clinical trial protocol and manuals to develop and negotiate comprehensive study budgets and payment terms.
• Inform the development and implementation of institutional and multi-institutional clinical trial and accompanying systems.
• Perform study protocol complexity analysis to drive the proper costing and effort application.
• Analyze and validate clinical trial financial systems design and operational workflows to optimize performance and productivity.
• Provide training and education to CTO colleagues, School of Medicine investigators, research staff and practice site staff on research budgeting and billing policies, procedures, and tools.
• Provide excellent customer service and accurate guidance to clinical research study teams regarding clinical research budgeting and billing policies and procedures. Keep study teams apprised of study status.
• Track projects through multiple milestone points in the CTO production database to inform analytics. Manage production tickets and communications regarding work performed in compliance with office policies, procedures, and standards.
• Ensure electronic and paper study files are created, updated, stored, and maintained according to established office practices, customer service standards, and UW record retention policies, from initial contact to study closeout and beyond.
• Assist faculty, staff, and others in interpreting internal and external research billing policies, determining applicable review requirements, and facilitating timely budget approval.

CTO Projects:
• Contribute to the development of the CTO metrics and other analytics for internal and external audiences.
• Assist in the development of standardized procedures and tools for clinical research budgeting and coverage analysis.
• Contribute to the development of the CTO website content, training materials and SOPs.
• Participate in internal and interdepartmental project teams as assigned.
• Analyze issues and quiries from clients and escalate as appropriate to the CTO leadership.
• Perform other duties as assigned.