The Clinical Research Services Office functions as a central service office, overseeing industry sponsored research contracting, clinical research billing compliance, OHSU's clinical trials management system, and federal reporting compliance. Additionally, the CRSO helps to set some of the standards and policies for the conduct of clinical research at OHSU. We also seek to engage clinical research staff in community building, training and education through partnering with other OHSU departments and teams via the Clinical Research United (CRU) initiative. To learn more, please visit https://www.ohsu.edu/clinical-research-services-office

 

The Senior Coverage Analyst (SCA) works both independently and collaboratively as an advanced professional resource supporting compliant clinical research billing at OHSU. The SCA reviews documents submitted to the Central Office and performs coverage analysis review. The SCA will conduct a detailed review of study documents to confirm the accuracy and integrity of submissions, perform the coverage analysis, and provide feedback to the study team until the analysis document is completed. The SCA facilitates compliant billing by providing expertise and guidance to the OHSU clinical research and healthcare billing communities regarding relevant National and Local Coverage Determinations, OHSU policies and institutional processes. The SCA leads the Coverage Analysis process, developing and overseeing the creation of Billing Grids detailing the appropriate billing designations for all services detailed in a clinical research protocol, informed consent, trial agreement, and other study-relevant documents. Working with the CRBO Manager, the SCA is responsible for team and OHSU community training, communication and advisory services. The SCA also creates/maintains policies and SOPs to standardize the review of study documents to indicate which medical procedures/services may be “Routine Cost” and billable to patient/insurance and which may be “Research” and billed to the study sponsor.

 

Program-specific overview:
This position works within the Clinical Research Billing Office. The Clinical Research Billing Office oversees and facilitates billing for clinical services performed in conjunction with clinical trials at OHSU to ensure compliance with all federal/state regulations, and OHSU policies and procedures. Projects and/or responsibilities in other clinical research support areas may also be assigned.

Independent review, analysis, support:  Using professional expertise and sound judgment, as well as analytical, organizational, and time management skills, perform independent, accurate and timely review and analysis of research billing inquiries to resolve, provide guidance, and collaborate with other staff for resolution. Appy advanced knowledge of federal, state, local, and OHSU statutes, regulations, guidance, and policies and procedures, as well as relevant technology to:

• Provide advanced professional coverage analysis and serve as main resource for other staff and the OHSU research community
• Respond to any inquiries pertaining to the Coverage Analysis process
• Address incoming inquiries to resolve and/or delegate to other team members
• Lead the determination of whether proposed clinical research studies are a qualifying clinical trial (QCT) as defined by the Medicare Clinical Trial Policy (NCD 310.1); designate medical procedures/services based on relevant regulations and determinations.
• Effectively communicate results to study teams to ensure consensus regarding research costs vs. routine costs.
• Maintain a comprehensive database (Smartsheet) of all Coverage Analysis request submissions to track overall progress of each review.
• Serve as an expert institutional resource related to Medicare billing rules and a functional expert on the internal process supporting compliant clinical research billing.
• Provide ongoing education related to CRBO Coverage Analysis Policy to the OHSU research community
• Assist management and leadership to improve processes within and across clinical research by collaborating on the development of policies, procedures and recommendations to leadership. 

Training, communication, and advisory services*:  

• Work with CRBO manager to develop and implement education and communication outreach activities that will provide and document accurate and continuous research billing education programs for the OHSU community.  
• Collaborate with CRBO manager to develop and implement internal clinical research billing compliance education activities to continuously improve research billing compliance and related areas. 

 Policies and procedures*:  

• Identify deficiencies and advise on how to achieve compliance with regulatory requirements in an efficient manner.  
• Lead ongoing assessment of the Coverage Analysis process with a goal of streamlining and improving overall flow; implement new and/or maintain existing policies and procedural changes. 

Continuous Quality Improvement*: 

• Lead the continuous quality improvement initiatives for the Coverage Analysis process in partnership with the CRBO manager. 
• Identify weaknesses and deficiencies and provide input to CRBO manager on how to enhance the quality and efficiency of the work performed. 

Technology liaison*:

• Collaborate with Epic Research Revenue Cycle and CTMS Support to provide input, evaluate and test clinical research billing functionality in Epic and the CTMS. 

Other duties as assigned*:

• Other special projects, as determined by CRBO manager.  

• Bachelor’s degree in related field.

• 7 years of relevant experience in clinical research, billing compliance, or related.

• Ability to effectively work both independently and in a team environment.

• Effective organizational abilities, oral and written communication skills, and interpersonal skills.

• Ability to operate and communicate effectively while meeting multiple deadlines and completing projects simultaneously.

• Ability to interact in a positive, productive manner with researchers, staff and leadership (demonstrating sensitivity, tact, and professionalism).

• Master’s degree in a related field.
• Experience in clinical trial finance, clinical trial coordination, clinical trial management systems, healthcare billing.

• Understanding of Epic functionality and workflows, particularly as related to hospital and professional billing.

• Advanced knowledge in federal and state laws, regulations, and guidance relating to clinical research billing.

• Have or obtain within 1 year of hire applicable or related certification, such as CIP, CPIA, ACRP or SoCRA certification

Please list work experience in months and years on resume.

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.