Clinical Research Budget Analyst – School of Medicine, Clinical Trials Office

University of Washington•Seattle, WA

2d•Onsite

About The Position

The Clinical Trials Office (CTO) has an outstanding opportunity for a Clinical Research Budget Analyst to join their team. Reporting to the Coverage Analysis Manager, the Clinical Research Budget Analyst (Analyst) serves as a subject matter expert in coverage analysis as well as budget analysis and negotiation with industry biotech and biopharma sponsors. The Analyst must use rigorous analytical ability and knowledge of guidelines for medical services across the full range of medical specialties in order to provide Medicare Coverage Analysis and Compliance Review. This position understands the downstream impacts to clinical trial budget development, negotiation and post award services. The Analyst combines attention to detail with efficient management of a portfolio of diverse clinical trial protocols.

Requirements

Bachelor's degree in science, business, healthcare administration or related field.
Three or more years’ experience with coverage analysis, clinical research study coordination or management, health systems operations, or related research or healthcare experience.
Ability to make positive contributions and work effectively and efficiently in a group environment.
Working knowledge of the Medicare Clinical Trials Policy and other Federal, State and institutional clinical research regulations.
Exceptional customer service skills.
Strong written and oral presentation skills.
Ability to communicate effectively with all levels of staff, faculty, management and collaborators.
Ability to understand and 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 in a fast-paced, high-volume setting.
Demonstrated skill in using Microsoft Excel and Access.

Nice To Haves

Master's degree in business or healthcare administration, or related field.
Experience working in OnCore or other CTMS systems.
Coverage analysis certification or ACRP or SOCRA credentialing (CCRC, CCRP)
Experience working with an intake ticketing system.

Responsibilities

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.
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.