Director, Clinical Research Billing
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Job Description
Director overseeing clinical research billing compliance, revenue cycle, and staff operations at Stanford Health Care. Managing coverage analysis, audits, invoicing, and clinical trial billing workflows.
Responsibilities:
- Oversee the clinical research billing infrastructure, including coverage analysis, clinical research budgets, calendars, research charge review, research charge master, and sponsor invoicing
- Ensure financial sustainability supporting sponsors and external collaborators
- Develop and implement comprehensive clinical research billing compliance programs
- Collaborate with Principal Investigators, study sponsors, study teams, finance/accounting, revenue cycle, internal audit, compliance, business office leaders, and clinic operational teams
- Manage selection, scheduling, supervision, retention, evaluation, development, and mentoring of Clinical Research Billing staff
- Lead department meetings, performance appraisals, feedback sessions, coaching, corrective counseling, and recognition activities
- Facilitate team dynamics, team-building, and departmental process improvements
- Lead the Clinical Research Billing Compliance Committee
- Manage research billing and coverage analysis resources, including internal or vendor resources
- Review study calendars, coverage analysis, and study expenses
- Oversee post-award revenue cycle activities, research charge review, patient care billing for clinical trials, revenue capture and reimbursement trends, and financial forecasting
- Develop policies, procedures, and workflows for clinical research billing
- Deliver successful collection results against 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, priorities, standards, and activities
- Contribute to and manage training programs for clinical research revenue cycle participants
- Implement and monitor compliance components involving coverage analysis, Epic Research Billing Charge Review, and OnCore Clinical Trial Management System
- Design, manage, and complete research billing compliance audits and use audit results to drive education
- Respond to research billing non-compliance and collaborate with Internal Audit and Business Practices on deficiencies and process improvements
- Maintain documentation and evidence of compliance for regulatory inspections and audits
- Monitor regulatory, payer policy, industry, Epic, and OnCore changes and communicate impacts to executive leadership
- Ensure adherence to internal controls and provide quality assurance for research billing processes
- Identify billing and coding inaccuracies and address process gaps with interdisciplinary teams
- Optimize information systems, data management, analysis, and Epic research-related workflows
- Apply lean principles to process improvements
- Partner with the School of Medicine to improve study activation through feasibility analysis, service identification/pricing, and pre-award budgeting
- Ensure a safe and effective working environment and monitor safety, accreditation, regulatory, infection control, and staff competency requirements
- Develop and deploy training and education materials with Revenue Cycle and School of Medicine training teams
- Assist with department budgeting, expense management, staffing plans, schedules, and financial targets
- Ensure coverage analysis fees are invoiced and paid timely
- Analyze clinical trial billing profit and loss and guide charge description master and fee schedules
- Provide financial status reports to study teams and investigators
- Lead workflow and practice changes, Epic build/configuration input, change initiatives, and sustainable action plans
- Build strategic relationships across teams, departments, and units
- Identify and address developmental needs of self and staff
Requirements:
- 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
- Advanced knowledge of CMS billing rules and regulations, including National Coverage Determinations, Local Coverage Determinations, and Clinical Trial Policy (NCD 310.1)
- Strong understanding of the clinical research lifecycle, including coverage analysis, research charge review, budgeting, and sponsor invoicing
- Advanced knowledge of CPT/HCPCS and healthcare terminology
- Understanding of physician and hospital billing
- Ability to communicate effectively with patients, physicians, family members, and co-workers
- Leadership, critical thinking, self-direction, initiative, interpersonal, and oral/written communication skills
- Ability to analyze data, identify issues and opportunities, draw conclusions, and develop appropriate solutions
- Ability to work effectively in a fast-paced environment
- Flexibility and adaptability
- Excellent analytical and interpersonal skills
- Sound judgment in applying and interpreting compliance policies, procedures, laws, rules, and regulations
- Excellent problem-solving skills and technical knowledge related to financial and clinical research billing challenges
- Demonstrates skills and competencies necessary to safely perform the assigned job through ongoing assessments and evaluations
- Must maintain required credentials demonstrating competency per accrediting agency or department guidelines, as applicable
- Must adopt and execute C-I-CARE standards for patients, families, and colleagues
Benefits:
- Equal opportunity and non-discrimination in employment
- Consideration of qualified applicants with criminal convictions after individualized assessment
- Employee patient and family experience framework and support
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