What You Will Need:

EDUCATION AND EXPERIENCE REQUIRED:

• Associate degree in healthcare related field (healthcare finance, medical coding, administration or research related field); OR
• Equivalent work experience in healthcare, clinical research, research billing, or related field, AND
• One year or more of work experience in a clinical research environment including a stand-alone research site, a research department, or in research administration such as a centralized research office, or with an institutional review board
• Experienced in medical billing, medical coding, or revenue cycle within a healthcare setting

EDUCATION AND EXPERIENCE PREFERRED:

• • Bachelor’s degree in healthcare, administration, or research related field
  • Two years or more of experience working in a clinical research environment including a stand-alone research site, a research department, or in research administration such as a centralized research office, or with an institutional review board.
  • Experience in areas of research regulatory compliance, especially related to clinical trials billing

KNOWLEDGE AND SKILLS REQUIRED:

• Knowledge of federal regulations related to clinical trials billing
• Awareness of the concepts of routine costs versus research related costs, research budget build, Medicare coverage analysis (MCA), and billing grids as related to clinical research
• Knowledge of electronic hospital and/or medical practice billing systems in the healthcare setting
• Computer skills including MS Office, Outlook, Word and Excel
• Excellent verbal and written communication skills including ability to interact with varied professionals
• Ability to work independently with attention to detail
• Self-motivated with good time management and organizational skills
• Ability to maintain strict confidentiality of employees, other research team members, patients, research subjects, and institution (AH) information, especially related to patient health information and patient financial records reviewed as part of the job duties

KNOWLEDGE AND SKILLS PREFERRED:

• Working knowledge of the Centers for Medicare and Medicaid Services (CMS) Clinical Trial Policy for Routine Costs in Clinical Trials, National Coverage Determinations (NCD) §310.1, CMS policies for coverage of Investigational Devices (category A and B devices), CMS policy on Coverage with Evidence Development (CED), and Local Coverage Determination (LCD) decisions related to clinical trials billing
• Knowledge of electronic management systems for research, especially IRBNet and/or Clinical Conductor
• Knowledge of the Cerner Patient Accounting and/or the Athena billing systems in the healthcare setting

Job Summary:

• Ensure all necessary parties are notified in a timely manner, of new clinical trials being implemented. Ensuring information needed to set up the research account or equivalent in the appropriate patient accounting systems, prior to patient recruitment beginning for the clinical trial. Necessary parties include Adventist Information Technology (AIT), AH and AHMG Revenue Cycle teams, and all associated ancillary services including laboratory, pathology, and radiology services.

• Manages research work item list within the hospital accounting program daily, identifying research related patient visits and communicates information necessary for accurate clinical trial charge delineation (research related billable items/services versus non-billable research funded items/services) to the appropriate parties within the accounting application.

• Communicates the correct delineation of charges that are outside of the hospital accounting work item list to the necessary parties (including AH and AHMG Rev Cycle teams and applicable ancillary services including laboratory, pathology, and radiology services) for all research related patient visits as documented in the associated Coverage Analysis (CA) and/or billing grids.

• Serve as liaison between clinical research teams and AH and AHMG Revenue Cycle teams and all applicable ancillary teams (including laboratory, pathology, and radiology) to assist with questions regarding coverage analysis, billing grids, patient research visit details, etc. for the resolution of research accounts and to facilitate accurate and compliant clinical trials billing activities utilizing the Clinical Trial Management System (CTMS) as a resource and clarifying with the research teams when necessary.

• Ensures all necessary parties are notified when research patients have completed a trial, or the termination or disenrollment of a patient from any clinical trial.

• Performs monitoring of research patient account notifications to AH PFS, AHMG Revenue Cycle, and all associated ancillary services including laboratory, pathology, and radiology services. Performs monitoring to ensure patient enrollment is current and accurate within the current electronic applications.

• Maintain current master list of all active research studies with necessary information to track for clinical trials billing compliance and management purposes.

• Upload documents necessary for clinical trials billing compliance to an application shared with all stakeholders to facilitate ease of accessing the documents for proper, accurate, and timely billing and invoicing activities.

• Offers input in the development/revision of ORI P&Ps related to clinical trials billing, the ongoing risk assessment of the AH Research Institute and the ORI compliance program’s effectiveness related to clinical trial billing issues.

• Assists with the facilitation of communication to independent physicians who may be conducting research at AH to assist them in research billing compliance at their offices.

• Prepares or assists with the preparation of reports as needed for internal/external individuals and/or entities including AH PFS, AHMG Revenue Cycle, AH Research Finance, and AHRI Leadership.

• Assist with developing tools and guidance to aid investigators, research staff, billing and coding staff to develop, perform and maintain compliant clinical trials billing activities.

• Facilitates and promotes activities to foster effective communication and information deployment regarding ORI P&Ps and federal regulations related to clinical trials billing compliance awareness within AH.

• Assists with process improvement initiatives to facilitate/maintain communication between clinical research teams and AH/AHMG/ancillary services (includes laboratory, pathology, radiology) and the Revenue Cycle billing teams.

• Manages and/or assists with other duties as assigned by leadership.