Clinical Research Budget Analyst

This posting will be used to recruit for 2 positions.
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.
The School of Medicine has an outstanding opportunity for a Clinical Research Budget Analyst to join their team.
The Clinical Research Budget Analyst will serve as a subject matter expert in coverage analysis as well as budget analysis and negotiation with industry biotech and biopharma sponsors. Ability to work collaboratively in a group setting in a fast-paced environment is crucial in this role.
Regulations governing Medicare Coverage Analysis including NCD's, LCD's, LCA's, FDA approvals for drugs & devices and 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 guidelines for medical services across the full range of medical specialties in order to provide Medicare Coverage Analysis and Compliance Review. This position will need to know the downstream impacts to tho clinical trial budget development, negotiation and post award services. Attention to detail must be combined with efficient management of a portfolio of diverse clinical trial protocols.
The 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 the 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. The CTO Coverage Analysis Team Lead is a key position in maintaining a secure and fully compliant CTO operation.
DUTIES AND RESPONSIBILITIES
Coverage Analysis:

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 inquiries from clients and escalate as appropriate to the CTO leadership.

Perform other duties as assigned.

MINIMUM QUALIFICATIONS

A Bachelor’s degree in science, business, healthcare administration or related field and at least three years’ experience with coverage analysis, CLINICAL RESEARCH study coordination or management, health system operations, or other related research or healthcare experience.

Additional requirements:

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.

Equivalent education and/or experience may substitute for minimum requirements.
DESIRED QUALIFICATIONS

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.

Accounting and finance experience.

Budget development and negotiation experience

Experience as a research study coordinator and/or fiscal specialist in a healthcare setting.

CONDITIONS OF EMPLOYMENT
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.