Director - Clinical Research Billing (Remote - CA)

1.0 FTE Full time, 8-hour day shift (United States of America)

About the role

The Director of Clinical Research Billing will oversee the clinical research billing infrastructure—including coverage analysis, clinical research budgets, calendars, research charge review, development and maintenance of the research charge master, and sponsor invoicing—to provide efficient, compliant, and innovative support to the research community. This leadership role ensures financial sustainability to attract sponsors and external collaborators while developing and implementing comprehensive compliance programs that adhere to all applicable laws, regulations, and institutional policies.

The Director will collaborate with a broad set of stakeholders, including Principal Investigators, study sponsors, study teams, finance/accounting, revenue cycle, internal audit, compliance, business office leaders, and clinic operational teams, ensuring clear communication regarding processes and billing compliance regulations. Responsibilities include managing departmental staff, setting departmental vision, and overseeing all activities related to coverage analysis, calendars, research charge review, and sponsor invoicing to ensure compliance with laws and policies.

The role also involves developing and implementing unified policies, procedures, education, and training related to research billing for revenue cycle staff, investigators, and clinical research staff.

Responsibilities

• Perform management responsibilities, including selection, scheduling, supervision, retention, and evaluation of employees in the Clinical Research Billing department. Provide development and mentoring of staff.
• Conduct regular department meetings to review policies, procedures, and operational matters; round on all employees; complete performance appraisals; and provide coaching, corrective counseling, and recognition.
• Facilitate and promote effective team dynamics and team-building strategies within and between departments; lead and participate in process improvements.
• Facilitate/lead a Clinical Research Billing Committee with members from research, compliance, clinical, and financial areas to support compliance.
• Manage Research Billing and Coverage Analysis resources (internal or vendor).
• Review study calendars, coverage analysis, and study expenses.
• Oversee revenue cycle post-award activities, including research charge review, patient care billing for clinical trials, reviewing trends in revenue capture and reimbursement, and forecasting financial impacts.
• Develop policies, procedures, and workflows associated with clinical research billing.
• Achieve successful collection results using industry KPI and benchmark metrics.
• Partner with study teams, School of Medicine, Revenue Cycle, Compliance, and Internal Audit.
• Manage day-to-day department operations, schedules, and activities; set priorities and functional standards to ensure high customer/patient satisfaction.
• Drive department service standards to impact customer-based satisfaction; serve and actively participate on entity committees.
• Contribute to the development and management of a training program for individuals involved in the clinical research revenue cycle process.
• Develop and maintain a compliance program addressing coverage analysis, clinical research budget reconciliation, calendars, research charge review, and study invoicing.
• Implement and monitor compliance program components such as coverage analysis, Epic Research Billing Charge Review, and optimal use of the OnCore Clinical Trial Management System.
• Manage the design, execution, and completion of research billing compliance audits; use audit results to drive educational programs.
• Respond to reported, suspected, or confirmed instances of research billing non-compliance; collaborate with Internal Audit and Business Practices to address deficiencies.
• Provide ongoing training and education to staff on compliance procedures and requirements.
• Ensure organizational preparedness for regulatory inspections or audits by maintaining accurate and up-to-date documentation.
• Stay informed of regulatory compliance, payer policy changes, industry trends, and best practices; communicate impacts to executive leadership.
• Ensure strict adherence to internal controls.
• Provide oversight and quality assurance for coverage analysis, calendar builds, budgets, research charge review, and sponsor invoicing.
• Identify process gaps and potential billing and coding inaccuracies; work with interdisciplinary teams to address these gaps.
• Use and optimize information systems to enhance operations; support performance improvement and data management/analysis functions.
• Adopt lean principles in driving process improvements.
• Partner with the School of Medicine to optimize study activation time through feasibility analysis, service identification/pricing, and pre-award budgeting process improvement.
• Ensure a safe and effective working environment; monitor and revise the department safety plan and accreditation/regulatory required safety guidelines.
• Collaborate with Revenue Cycle and School of Medicine training teams to develop and deploy training and education materials.
• Assist in the development of the department budget and ensure cost-effective operations; manage expenses within approved budget parameters.
• Develop staffing plans and schedules to meet department/patient needs while maintaining cost-effectiveness.
• Ensure timely invoicing and payment of coverage analysis fees by the School of Medicine department/division/study.
• Assist in the analysis of profit and loss associated with clinical trial billing; provide guidance on clinical trial charge description master and fee schedules.
• Implement department strategies to achieve financial targets and staffing needs through optimizing productivity and resource efficiency.
• Provide accurate and timely financial status reports to study teams and investigators.
• Identify and implement innovative solutions for workflow changes to improve department operations.
• Develop and optimize workflows associated with Epic research-related modules; provide operational input for Epic build/configuration.
• Support change initiatives and maintain effectiveness in evolving work environments.
• Proactively evaluate processes; recommend and implement action plans for sustainable change.
• Participate in the development and implementation of new procedures and review/revision of existing procedures.
• Build strategic relationships between departments to achieve business goals.
• Identify developmental needs of self and staff and take appropriate action.

Qualifications

• Bachelor’s Degree in Business, Finance, Health Care Administration, or a related field.
• Eight (8) years of progressive management experience in clinical research operations.
• At least five (5) years of progressive experience related to research finance/billing compliance.

Skills

• Demonstrates skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations.
• Advanced knowledge of CMS billing rules and regulations, including National Coverage Determinations, Local Coverage Determinations, and the Clinical Trial Policy (NCD 310.1).
• Strong understanding of the overall clinical research lifecycle, especially coverage analysis, research charge review, budgeting, and sponsor invoicing processes.
• Advanced knowledge of CPT/HCPCS and other healthcare-related terminology.
• Understanding of physician and hospital billing.
• Ability to effectively communicate through various channels with patients, physicians, family members, and co-workers in a customer service-focused manner.
• Leadership qualities and critical thinking through self-direction, initiative, and effective interpersonal and communication skills.
• Ability to identify and understand issues, problems, and opportunities; use effective approaches for choosing a course of action or developing solutions.
• Ability to work effectively in a fast-paced environment.
• Flexibility and adaptability in the workplace.
• Excellent analytical and interpretive skills.