A Brief Overview
The Director of Clinical Research Billing will be responsible for ensuring and overseeing the clinical research billing infrastructure (coverage analysis, clinical research budgets, calendars, research charge review, development and maintenance of research charge master, and sponsor invoicing) to provide the most efficient, compliant, and innovative support to meet the needs of the research community.

As a leader, the Director of Clinical Research Billing will work to ensure financial sustainability that attracts sponsors and external collaborators. Additionally, the Director will be responsible for developing and implementing comprehensive compliance programs to ensure adherence to all applicable laws, regulations, and institutional policies. The Director of Clinical Research Billing will collaborate and have direct interaction with a broad set of stakeholders across the institution, including Principal Investigators, study sponsors, study teams, finance/accounting, revenue cycle, internal audit, compliance, business office leaders, and clinic operational teams. In doing such, the Director will ensure open and clear communication with respect to processes and billing compliance regulations.

The Director's responsibilities include overseeing the management of departmental staff and ensuring department management's clarity of vision and efficiency of processes. In addition, this role will require oversight of direction for all activities associated with coverage analysis, calendars, research charge review/segregation, and sponsor invoicing - specifically ensuring that these documents and processes are conducted in compliance with all applicable laws, regulations, and institutional policies. The Director of Clinical Research Billing sets the direction for developing and implementing unified policies, procedures, education, and training related to research billing for revenue cycle staff, investigators and staff conducting clinical research.

Locations
Stanford Health Care

What you will do

• Perform management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees in the Clinical Research Billing department. Provide development and mentoring of staff. Meets or exceeds threshold goal for department turnover. Develop direct reports to perform these same functions.
• Provide fair and consistent leadership and communication to maintain a competent and engaged employee group by conducting regular Clinical Research Billing department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/recommendations to achieve desired outcomes.
• Facilitate and promote effective team dynamics and team-building strategies within and between departments; participate and/or lead and facilitate department process improvements as needed.
• Meet or exceed threshold goal for department and/or system metrics on employee engagement indicators.
• Facilitate/Lead a Clinical Research Billing Committee comprised of members from research, compliance, clinical and financial areas to support Clinical Research Billing Compliance.
• Manage Research Billing and Coverage Analysis resources (internal or vendor)
• Responsible for reviewing study calendars, coverage analysis, and study expenses.
• Responsible for overseeing revenue cycle post-award activities, such as research charge review, patient care billing for all clinical trials, reviewing trends in revenue capture and reimbursement, and forecasting financial impacts pertaining to clinical research activities.
• Develop policies and procedures and workflows associated with clinical research billing.
• Deliver successful collection results with industry KPI and benchmark metrics.
• Partners 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, giving direction to staff as necessary to ensure the best possible delivery of service and high customer/patient satisfaction.
• Drive department service standards and activities to impact department and/or system score for customer-based satisfaction, through role modeling and fostering accountability. Serve and actively participate on various entity committees as a voice for the department.
• Contribute to the development and management of a training program for all individuals involved in the clinical research revenue cycle process, including research and non-research professionals.
• Develop and maintain a compliance program that address all aspects of clinical research billing, including coverage analysis, clinical research budget reconciliation (harmonization), calendars, research charge review, and study invoicing.
• Implement and monitor assigned relevant 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, management, and completion of an array of research billing compliance audits that are designed to determine compliance with policies, procedures, laws, rules, and regulations. Utilize the results of audits performed to drive a comprehensive educational program.
• Respond to reported, suspected, or confirmed instances of research billing non-compliance. Participate in Compliance and other committees as required. Work collaboratively with the Internal Audit and Business Practices to respond to deficiencies and to strengthen research billing internal processes.
• Provide ongoing training and education to staff on compliance procedures and requirements to ensure that all team members are knowledgeable about current regulations and best practices.
• Ensure that the organization is prepared for regulatory inspections or audits by maintaining accurate and up-to-date documentation and evidence of compliance.
• Stay informed of regulatory compliance, payer policy changes, industry trends, and best practices that impact and/or influence billing policies and procedures, and Epic/OnCore system changes. Communicate impact to executive leadership timely and appropriately.
• Ensure strict adherence to internal controls is maintained.
• Provide oversight and quality assurance for coverage analysis, calendar builds, budgets, research charge review, and sponsor invoicing, as needed.
• Identify process gaps and potential billing and coding inaccuracies and work with interdisciplinary teams to address these gaps.
• Use and optimize information systems to enhance operations; supports entity-specific 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 by participating in feasibility analysis, service identification/pricing and pre-award budgeting process improvement
• Ensure a safe and effective working environment; monitor and/or revise the department safety plan and/or any specific accreditation/regulatory required safety guidelines, including infection control principles. Monitor and confirm staff maintain their required credentials that demonstrate competency per accrediting agency or department guidelines as applicable.
• Collaborate with Revenue Cycle and School of Medicine training teams to develop and deploy training and education materials.
• Assist in the development of department budget and ensure that the department operates in a cost-effective manner. Manage/audit department expenses within approved budget parameters, ensuring that the department meets the budgeted/flex revenue and/or expense targets on a monthly and annual basis. Develop staffing plans and schedules to meet department/patient needs that reflect understanding of the importance of cost-effectiveness.
• Ensure that coverage analysis fees are invoiced and paid timely 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 target and staffing needs, developing others to do the same, through optimizing productivity, supply/resource efficiency, minimizing incidental overtime and overtime percentage, and other areas according to department specifications.
• Provide accurate and timely financial status reports to the study teams and investigators.
• Identify and implement innovative solutions for practice or workflow changes to improve department operations or other department-specific measures by leading unit projects and/or other department/system directed/shared governance activities. Develop and optimize the workflows associated with the use of Epic research related modules, providing operational input for Epic build/configuration. Support change initiatives, maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjust effectively to work within new work structures, processes, requirements, or cultures.
• Proactively evaluate processes; recommend and implement action plan(s) for change; follow through to ensure effective, sustainable change. Participate in the development and implementation of new procedures and the review and revision of existing procedures.
• Identify opportunities and take action to build strategic relationships between one's area and other areas, teams, departments, and units to achieve business goals.
• Seek opportunities to identify developmental needs of self and staff and take appropriate action.

Education Qualifications

• Bachelor's Degree in Business, Finance, Health Care Administration, or a related field.

Experience Qualifications

• 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.

Required Knowledge, Skills and Abilities

• Demonstrates the 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 such as National Coverage Determinations, Local Coverage Determinations, and specifically 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.
• Demonstrates an understanding of physician and hospital billing.
• Ability to effectively communicate through a variety of channels with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles; engages the recipient(s) and helps them understand and retain the message.
• Demonstrates leadership qualities and critical thinking through self-direction initiative and effective interpersonal skills and oral/written communication skills.
• Ability to identify and understand issues, problems, and opportunities, comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
• Ability to work effectively in a fast-paced environment.
• Demonstrates flexibility and adaptability in the workplace.
• Excellent analytical and interpersonal skills.
• Applies sound judgment in applying and interpreting policies, procedures, laws, rules, and regulations applying to compliance and monitoring.
• Excellent problem-solving skills, including but not limited to creativity, adaptability, resourcefulness, timeliness, and technical knowledge related to analyzing and resolving financial, compliance, issue escalation/resolution and/or institutional challenges impacting clinical research through the lens of billing

Base Pay Scale: Generally starting at $94.35 - $125.03 per hour
<