Clinical Research Budget Analyst

University of Washington•Seattle, WA

About The Position

The University of Washington (UW) is proud to be one of the nation’s premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research, and community service. Our staff not only enjoy outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty. UW Medicine works to improve the health of the public by advancing medical knowledge, providing outstanding primary and specialty medical care to people of the region, and preparing tomorrow’s physicians, scientists and other health professionals. Within the large UW Medicine health system, the School of Medicine (SOM) is a world leader in biomedical research, with the largest biomedical research program at a public university based on National Institutes of Health funding and ranking among the top research universities internationally. The Clinical Trials Office (CTO) supports the clinical research mission of UW Medicine. The CTO is an operational unit within the SOM’s Office of Research and Graduate Education charged with providing multi-service support to clinical researchers, bringing important new therapies to our patients in compliance with evolving regulatory requirements. POSITION SUMMARY The Clinical Trials Office has an outstanding opportunity for a Clinical Research Budget Analyst (Budget Analyst). Reporting to the CTO Manager of Trial Start-up and Special Projects, the Budget Analyst position is responsible for developing and negotiating budgets and payment terms of clinical trial agreements for clinical trials and clinical research studies across multiple therapeutic areas. This position is responsible for drafting budgets and performing negotiations with industry biotech and biopharma sponsors on complex clinical trial protocols while adhering to aggressive trial start-up timeline goals. Ability to work collaboratively in a group setting in a fast-paced environment is crucial in this role. POSITION IMPACT TO THE UNIVERSITY Clinical Trials Office is a central clinical research operation with compliance responsibilities and services across the vast portfolio of clinical trials in UW Medicine. The CTO operation has direct impact on UW reputation with major global biotech and biopharma sponsors, the availability of funded clinical trial opportunities in UW pipeline, and UW patients' access to novel therapies. 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. CTO Budget Analyst is a key position in maintaining secure and fully compliant CTO operation.

Requirements

A Bachelor’s degree in science, business, healthcare administration or related field and at least three years’ experience with clinical trial budget development and negotiation, coverage analysis, clinical research study coordination or management, health system operations, or other related research or healthcare experience.
Equivalent education and/or experience will be considered.
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 system.
Coverage analysis certification or ACRP or SOCRA credentialing (CCRC, CCRP).
Experience working with an intake ticketing system performance.
Accounting and finance experience.
Experience as a research study coordinator and/or fiscal specialist in a healthcare setting.

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 thorough review of study calendars, research coding, and coverage analysis of research procedures in alignment with CMS rules and analyze audit-ready study billing grids.
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 policies, determining applicable review requirements, and facilitating timely budget approval.
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.
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.