Billing Compliance and Quality Control Analyst - Clinical Trials Office

Job Description

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.

The Billing Compliance & QC Analyst will serve as a subject matter expert in the comprehensive and independent final compliance review (Summary Review) of all documents related to research study funding, including the research study budget, protocol, contractual terms, informed consent, and other supporting documentation.  The incumbent will additionally function as a subject matter expert with CTO production workflows and systems processes, and will offer suggestions for optimization strategies. This position will assist with training internal staff on processes and systems and will educate CTO customers on workflows and expectations. Ability to work collaboratively in a group setting in a fast-paced environment is crucial in this role.

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’s 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 CMS and FDA regulations and guidelines. The Billing Compliance & QC Analyst is a key position in maintaining a secure and fully compliant CTO operation.

DUTIES AND RESPONSIBLITIES

Workflow and Billing Compliance – 40%

• Perform comprehensive and independent analysis of systems processes pertaining to CTO review workflows.
• Regularly update and work with the Clinical Trial Management System (OnCore), Zendesk (ZD) Customer Service Management tool, the CTO Database (CTODB), and other comprehensive electronic study documentation for each clinical research study, in compliance with UW policies, procedures and standards.
• 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.
• 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 final compliance review (Summary Review) of all documents related to research study funding, including the research study budget, protocol, contractual terms, informed consent, and other supporting documentation.
• Review and finalize study Billing Grids, ensuring proper documentation of Coverage Analysis decisions.
• Provide excellent customer service and accurate guidance to clinical research study teams and keep them apprised of study status.
• Track studies 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.
• Effectively collaborate with and communicate important information to external investigators and research teams at partner institutions (e.g., Fred Hutchinson Cancer Center and Seattle Children’s).
• Contribute to the development of the CTO website content, training materials, and SOPs.
• Participate in internal and interdepartmental project teams within UW Medicine as assigned.
• Under the guidance of the Manager and Sr. Workflow Lead, provide training for new and existing team members.
• Perform other clinical research finance-related duties, as required.

Quality Assurance (QA)/Quality Check (QC) – 60%

• Assist with implementing strategies to achieve and maintain the service and quality goals for the CTO Clinical Research Finance Team.
• Offer suggestions for optimization strategies that contribute to CTO metrics and other analytics for internal and external audiences.
• Perform QA, identifying root cause issues and addressing queries from clients, and escalate as appropriate to the Manager and Sr. Workflow Lead.
• Perform QC of workflow pathways for proper routing of studies through the start-up process.
• Perform QC of final compliance review (Summary Review) for team members training in the workflow.
• Perform QC of the Coverage Analysis work performed by a third party or internal CTO staff.  Ensure Coverage Analysts have designated study items and services as non-covered research-only or covered routine, in compliance with Medicare coverage rules.
• Perform final QC of clinical trial budgets that have been internally developed and negotiated with pharmaceutical and biotechnology corporate sponsors, contract research organizations and other sponsor institutions.
• Perform data QC to ensure accuracy and alignment across multiple systems (OnCore, Epic, Zendesk, CTO Database, etc.).

MINIMUM REQUIREMENTS

• A Bachelor’s degree in science, business, healthcare administration or related field and at least three years’ related experience or equivalent combination of experience and education.
• Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

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 effectively prioritize and organize work independently in a fast-paced, high-volume setting.
• Ability to work effectively and efficiently in a group environment.
• Demonstrated skill in using Microsoft Word, Excel, and Access.

DESIRED QUALIFICATIONS

• Master’s Degree in business or healthcare administration or related field.
• Experience working in OnCore or other CTMS system.
• Experience working with an Customer Service Management (CSM) ticketing system tool, such as Zendesk.
• Familiarity with electronic medical records and healthcare business systems. Experience working with web-based solutions.
• Experience in academic health system operations or medical setting.

Compensation, Benefits and Position Details

Pay Range Minimum:

Pay Range Maximum:

Other Compensation:

Benefits:

Shift:

Temporary or Regular?

FTE (Full-Time Equivalent):

Union/Bargaining Unit:

About the UW 

Working at the University of Washington provides a unique opportunity to change lives – on our campuses, in our state and around the world.  

UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty. 

Our Commitment 

The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81.

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu. 

Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.