YCCI Manager, Clinical Research Billing Compliance

Manager, Clinical Research Billing Compliance

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Salary Range: $82,000.00 - $131,500.00

Job Requisition ID: 137691WD

Overview

The Manager, Clinical Research Billing Compliance, leads and supports the day-to-day operations of clinical trial and research billing compliance activities. This role ensures accurate and compliant billing for research-related services by overseeing the Yale Center for Clinical Investigation (YCCI) Research Billing Compliance Team, consulting with the Financial Teams with YCCI's Protocol Activation and Lifecycle Management (PALM) team, advising on development of billing plans, and ongoing monitoring. This position is responsible for collaborating with all relevant departments within Yale, and Yale New Haven Health System (YNHHS) including YCCI-PALM, Yale clinical research study teams, YNHHS revenue cycle and research finance teams, etc.

Position Focus

Reporting to the Associate Director, Clinical Research Finance and Resource Utilization YCCI within the Yale School of Medicine, this position manages the development, implementation and monitoring of an effective clinical research billing compliance program, coordinating the clinical research billing reviews and monitoring efforts for clinical trials conducted at the Yale Medical School (including the School of Public Health). The position oversees an internal research billing compliance program and team; the implementation of quality control measures to promote safety and compliance and the integration of QA with multiple review committees. A critical component of the role is to identify to the Directors any compliance concerns and recommend solutions to improve the overall operations, the safe and efficient conduct of clinical trials and educational and training opportunities for faculty and staff.

Principal Responsibilities

• Leads, manages and advises on the current change management program for improving the clinical research billing compliance program at Yale. This includes working with current staff and vendors to develop, implement, monitor and report on outcomes of the updates and improvements being made to the current program. While the program will be in the change management process at time this position is filled, ongoing quality and change management will be expected for this role moving forward.
• Leads, manages, and advises on clinical research billing compliance matters as assigned. This includes serving as an expert resource regarding applicable laws, regulations, and standards governing clinical research billing conducted in the United States and other countries; providing advice and ensuring the efficient review, identification, and resolution of issues with a focus on customer service and compliance; and delivering relevant training.
• Leads, manages, and advises on clinical research billing compliance matters as assigned. This includes leading, managing, and advising on the following: clinical research billing compliance activities (e.g., Physician and Hospital Billing charge review, clinical research billing audits, Clinical Trial Management System (OnCore) patient billing plan set up and execution, research billing audits, etc.), systemic reviews to evaluate billing compliance to ensure compliance with all federal, state and local laws and regulations governing research billing compliance, responding to patient billing inquiries.
• Leads, manages, and advises on clinical trial billing operational matters and ensures operational efficiency and compliance with laws, regulations, and standards related to the conduct of clinical trial billing compliance. This includes leading, managing, and advising on the following: departmental and cross-departmental initiatives, projects, and requests for assistance by the University community; delivery of day-to-day service levels, customer experience, and billing compliance; change management within the billing compliance department in accordance with changes to laws and regulation governing the topic; collaborations with other business units; operational effectiveness and strategies to ensure quality and efficiency; operational opportunities, risk management, continuous quality improvement; and verifying that institutional requirements have been satisfied.
• Leads, manages, and advises on relationships external to the YCCI, YNHHS and University as assigned. This includes: facilitating discussions with research investigators, program directors and high-ranking officials from external institutions or organizations who are interested in pursuing a collaborative research affiliate relationship with Yale University; collaborating with ancillary committees, departments, and organizations external to Yale regarding clinical research billing.
• Leads, manages, and advises on matters related to YCCI accounts receivable, billing, and financial forecasting and reporting as assigned.

Required Skills and Abilities

1. Demonstrated expertise and a comprehensive understanding of applicable legal, regulatory, and medical terminology and ability to interpret, analyze, apply, and communicate (verbally and in writing) applicable ethical principles, standards, regulations, guidance, policies, and academic and industry trends that impact human research.

2. Demonstrated ability to manage, organize, and execute complex projects; multi-task, identify, analyze, and resolve problems efficiently and effectively; use independent good judgment and to assess risk; and independently follow-through on tasks, develop and execute work plans, prioritize work, and manage multiple assignments to meet deadlines.

3. Demonstrated ability to evaluate information, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies, and approaches; and ability to distill and communicate complex information into understandable information. Proactive, flexible, and customer service focused with the ability to work effectively with others; and demonstration of ethics and integrity in professional matters, sensitivity to confidentiality, and commitment to protecting research participants.

4. Demonstrated ability to provide guidance regarding clinical research billing compliance requirements and resolve issues. Demonstrated experience operating a successful billing compliance program at similar organization which includes all aspects of a clinical research billing compliance program including but not limited to: Understanding of Center for Medicare/Medicaid Services (CMS) laws, rules and regulations; National and Local Coverage Determinations; Coverage Analysis development and implementation within patient bills; experience with Clinical Trial Management System (CTMS) and Electronic Medical Records (EMR) system.

5. Demonstrated technology and software application skills; ability to learn new software packages; highly skilled in office productivity software (e.g., Word, PowerPoint, Excel, e-mail, Outlook, and Adobe, etc.); and knowledge of technology platforms used in research (e.g., Epic, Oncore, CRPC, IRB management, clinical trial management, and related platforms).

Preferred Education and Experience

1. 7 years of relevant experience in research administration or clinical research billing with 5 years prior experience at a large academic institution, hospital/medical center, academic/independent IRB, or non-profit organization/foundation.

2. At least 2 years managing a clinical research billing compliance team (inclusive of exposure to both pre and post award Clinical Research Billing practices) within a healthcare organization. Research Compliance, Certified Clinical Research Professional or other relevant certification.

3. Experience in a leadership/consultancy role.

4. Expert knowledge regarding Federally Funded/FDA regulated research regulations, ICH GCP, and the clinical trials process.