Billing And Compliance Manager

Billing And Compliance Manager Clinical ResearchThe Billing and Compliance Manager for Clinical Research leads and supports the day-to-day operations of clinical trial and research billing compliance activities. This role ensures accurate, timely, and compliant billing for research-related services by overseeing the clinical research billing compliance team, advising on billing plan development, and providing ongoing monitoring of clinical trial billing practices. The position manages the development, implementation, and continuous improvement of a comprehensive clinical research billing compliance program, integrating quality assurance with multiple review committees and collaborating closely with finance, revenue cycle, research administration, and clinical study teams. A key focus of the role is to identify compliance risks, recommend solutions, and create training and educational opportunities that promote the safe and efficient conduct of clinical trials.ResponsibilitiesLead, manage, and support the clinical research billing compliance team, including overseeing day-to-day operations and ensuring high-quality service delivery to research and finance stakeholders.Develop, implement, and monitor an effective clinical research billing compliance program that covers pre-award, activation, ongoing billing, and post-award activities for clinical trials and research studies.Drive and oversee a change management program to improve the clinical research billing compliance framework, working with internal staff and external vendors to design, implement, and report on process and system enhancements.Serve as the subject matter expert for clinical research billing compliance, providing authoritative guidance on applicable laws, regulations, standards, and ethical principles governing clinical research billing in the United States and internationally.Lead and manage clinical research billing compliance activities, including physician and hospital billing charge review, clinical research billing audits, Clinical Trial Management System (CTMS) billing plan setup and execution, and ongoing research billing audits.Conduct systemic reviews to evaluate billing compliance and ensure adherence to all federal, state, and local laws and regulations related to research billing, including CMS rules and National and Local Coverage Determinations.Respond to and resolve patient billing inquiries related to clinical research services with a strong customer service focus and commitment to compliance.Lead and advise on clinical trial billing operations, ensuring operational efficiency, regulatory compliance, and alignment with institutional requirements across departments and business units.Coordinate and support departmental and cross-departmental initiatives and projects related to billing compliance, operational effectiveness, risk management, and continuous quality improvement.Collaborate with internal and external stakeholders, including research investigators, program directors, and representatives from partner institutions, to facilitate discussions and initiatives related to clinical research billing and affiliate relationships.Provide leadership and oversight for accounts receivable, billing, financial forecasting, and reporting matters related to clinical research billing compliance, as assigned.Review and determine staffing needs, job posting requirements, and staff development strategies for the billing compliance function, ensuring appropriate staffing levels and skills to support program goals.Manage administrative support needs for exempt and non-exempt staff, recommending improvements, solutions, and assistance to enhance efficiency and effectiveness.Monitor and manage technology needs for assigned departments, including inventory and system requirements, to support billing compliance operations and research activities.Develop and prepare budgets, financial forecasts, and financial analyses, including actual versus budget performance reports, for departments involved in clinical research billing compliance.Oversee the use of facilities and resources such as office space, workstations, equipment, and supplies for the billing compliance and related administrative teams.Coordinate and manage training sessions for assigned departments when new policies, practices, or regulatory requirements are adopted, ensuring staff understand and follow updated procedures.Ensure compliance with institutional policies and federal regulations as they apply to assigned departments and clinical research billing activities.Identify, plan, and develop administrative policies for assigned departments, and assist in reviewing and implementing institutional and departmental policies related to administrative and billing functions.Assess staff development needs and staffing levels, making recommendations to support professional growth and operational effectiveness within the billing compliance team.Monitor, plan, and execute systematic research on user requirements through surveys, interviews, focus groups, and competitive analysis to inform improvements in billing compliance processes and systems.Manage a team currently consisting of four full-time employees, including staff focused on professional billing chart reviews and chart requests in CTMS, and a team member supporting post-award activities, post-billing review, and activation-related validation, with responsibility for leading future team growth.Provide ongoing training, coaching, and mentorship to team members, fostering a culture of compliance, integrity, customer service, and continuous improvement.Act as the organizations compliance leader for clinical research billing, setting expectations, enforcing compliance standards, and ensuring that policies and procedures are understood and followed.Proactively identify compliance concerns and operational risks related to clinical research billing, and recommend solutions and strategies to improve overall operations and the safe conduct of clinical trials.Collaborate with finance, research administration, clinical trial offices, IRB-related functions, and other stakeholders to ensure integrated, compliant, and efficient billing processes across the clinical research lifecycle.Perform other related duties as assigned to support clinical research billing compliance, research finance, and departmental operations.Essential SkillsDemonstrated expertise and comprehensive understanding of legal, regulatory, and medical terminology related to clinical research and billing, with the ability to interpret, analyze, apply, and clearly communicate ethical principles, standards, regulations, guidance, policies, and academic and industry trends that impact human research.Proven ability to manage, organize, and execute complex projects, including the capacity to multi-task, identify, analyze, and resolve problems efficiently and effectively, exercise sound independent judgment, assess risk, and follow through on tasks and work plans to meet deadlines.Strong analytical skills with the ability to evaluate information, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies, and approaches, while distilling complex information into clear, understandable messages for diverse audiences.Demonstrated ability to provide guidance on clinical research billing compliance requirements and resolve related issues, including experience operating a successful billing compliance program within a similar organization.In-depth understanding of Centers for Medicare & Medicaid Services (CMS) laws, rules, and regulations, including National and Local Coverage Determinations, and experience developing and implementing coverage analyses within patient bills.Hands-on experience with Clinical Trial Management Systems (CTMS) and Electronic Medical Records (EMR) systems in the context of clinical research billing.Demonstrated technology and software application skills, including the ability to learn new software packages and advanced proficiency with office productivity tools such as Word, PowerPoint, Excel, email, Outlook, and Adobe.Knowledge of technology platforms used in research, such as Epic and other systems supporting IRB management, clinical trial management, and related research operations.Experience interpreting and applying clinical research billing regulations, specifically including NCD 310.1 and related coverage rules.Proven billing compliance leadership experience, including leading teams and programs focused on clinical research billing compliance.Strong customer service and stakeholder management skills, with the ability to work effectively with investigators, administrators, finance teams, and clinical staff.Demonstrated experience enforcing compliance standards and training staff on compliance requirements in a healthcare or research environment.Ability and willingness to assess current processes, overhaul operations when necessary, and rebuild a stronger, more effective compliance framework.Bachelors degree in a related field and at least 5 years of relevant experience, or an equivalent combination of education and related experience.Demonstrated ethics and integrity in professional matters, sensitivity to confidentiality, and a strong commitment to protecting research participants.Additional Skills & QualificationsPreferred 7 years of relevant experience in research administration or clinical research billing, including at least 5 years of prior experience at a large academic institution, hospital or medical center, academic or independent IRB, or non-profit research organization.At least 2 years of experience managing a clinical research billing compliance team within a healthcare organization, with exposure to both pre-award and post-award clinical research billing practices.Experience in a leadership or consultancy role related to clinical research, billing compliance, or research administration.Expert knowledge of regulations governing federally funded and FDA-regulated research, including ICH GCP guidelines and the clinical trials process.Relevant professional certification such as Certified Clinical Research Professional or other research compliance-related credentials (strongly preferred).Demonstrated experience leading change management initiatives, including rebuilding or overhauling compliance programs and implementing new processes and systems.Strong communication skills, both verbal and written, with the ability to provide training, develop educational materials, and present complex regulatory and billing concepts clearly.Proactive, flexible, and customer-service-oriented mindset, with the ability to collaborate effectively across multiple departments and disciplines.Experience working in or with large, complex