SUMMARY:

The Coverage Analysis and Financial Quality Specialist serves as the primary resource for Coverage Analysis quality review, financial quality assurance, participant compensation verification, and clinical research billing compliance activities supporting study activation and post-activation operations across the Center for Clinical Research Management (CCRM).

Working under the direction of the CTO Administrative Manager within CCRM, the Specialist performs independent review and quality assessment of Coverage Analyses, sponsor budgets, participant compensation structures, and related financial activation documents to ensure accuracy, compliance, alignment, and operational readiness.

The Specialist collaborates with personnel across CCRM, including Clinical Trials Office (CTO), Clinical Trials Data and Technology, Intake, Regulatory, Research Finance, investigators, study teams, external vendors, and other stakeholders to identify and mitigate financial and billing compliance risk throughout the study lifecycle.

The Specialist serves as a key resource for financial quality assurance activities, billing compliance reviews, quality improvement initiatives, training, trend analysis, and process improvement efforts supporting CCRM.

Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another.

In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include:

Instill Trust and Value Differences
Patient and Community Focus and Collaborate

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Coverage Analysis and Financial Quality Review

• Serves as the primary quality reviewer for Coverage Analyses developed to support clinical trial activation.
• Reviews Coverage Analyses for accuracy, consistency, billing designation integrity, regulatory compliance, and alignment with study requirements and BUH Coverage Analysis specifications.
• Evaluates Coverage Analyses against study protocols, schedules of events, intake documentation, Medicare coverage guidance, institutional requirements, and related study documents.
• Identifies and resolves discrepancies between Coverage Analyses, internal budgets, sponsor budgets, and study documentation.
• Coordinates correction of identified issues with vendors, study teams, and applicable stakeholders.
• Works directly with vendors, study teams, and applicable CCRM personnel to resolve discrepancies identified during Coverage Analysis and financial quality review activities.

Sponsor Budget Quality Review

• Conducts quality review of negotiated sponsor budgets prior to investigator or departmental approval.
• Verifies accuracy of negotiated budget terms, calculations, institutional fees, pass-through costs, and sponsor payment responsibilities.
• Confirms alignment between the final negotiated sponsor budget, internal budget, and approved Coverage Analysis.
• Reviews participant compensation and reimbursement structures to ensure consistency across financial and operational study documents.
• Reviews budget-related protocol amendments and evaluates the financial impact of proposed changes.
• Ensures negotiation-driven changes affecting Coverage Analysis determinations are appropriately incorporated and documented.

Study Activation Support

• Participates in CCRM intake meetings to identify financial, billing, operational, participant compensation, and payer responsibility considerations that may affect study activation, Coverage Analysis development, or budget negotiation.
• Provides consultation regarding protocol-driven billing requirements, financial feasibility concerns, participant compensation models, and payer responsibility determinations.
• Supports study activation activities across CCRM by ensuring required Coverage Analysis, budget quality, participant compensation, and financial quality reviews have been completed prior to activation.
• Collaborates with Clinical Trials Office, Clinical Trials Data and Technology, Regulatory, Research Finance, and operational teams to support compliant and efficient study activation.

Billing Compliance and Post-Activation Support

• Serves as a resource for clinical research billing compliance activities.
• Provides cross-coverage support for research billing review functions during periods of staff absence, increased workload, or operational need.
• Assists with the review, investigation, and resolution of research billing discrepancies and compliance concerns.
• Provides cross-coverage support for amendment-related financial review activities, including Coverage Analysis updates, budget revisions, billing designations, participant compensation changes, and sponsor payment obligations, as operational needs require.
• Identifies trends, recurring findings, and opportunities for quality improvement related to clinical research billing activities.

Quality Improvement and Education

• Tracks and analyzes quality review findings, billing review trends, and recurring issue patterns.
• Develops recommendations for process improvement, training, and risk reduction.
• Assists with development and maintenance of standard operating procedures, guidance documents, training materials, and review tools.
• Provides education and training related to Coverage Analysis, research billing compliance, participant compensation, and financial quality review activities.
• Participates in CCRM workgroups, quality improvement initiatives, workflow redesign projects, and operational improvement efforts.
• Participates in internal audits and quality assurance activities as assigned.

Other Responsibilities

• Maintains documentation supporting quality review activities and findings.
• Serves as a liaison with external vendors regarding Coverage Analysis and budget-related quality issues.
• Performs other duties as assigned.

EDUCATION:

Advanced knowledge of clinical research operations, Coverage Analysis methodology, clinical research billing compliance, sponsor budget development, research finance principles, and study activation workflows.

Working knowledge of Medicare coverage guidance, qualifying clinical trial requirements, participant compensation practices, clinical trial agreements, and clinical research financial operations.

Demonstrated ability to evaluate complex research documents, identify discrepancies, assess risk, and recommend practical solutions.

Strong analytical, organizational, and problem-solving skills.

Ability to independently manage multiple priorities while maintaining accuracy and attention to detail.

Excellent written and verbal communication skills.

Ability to effectively collaborate with investigators, research personnel, vendors, finance staff, and operational stakeholders.

Proficiency with clinical research technology platforms including OnCore, Microsoft Office applications, and related reporting and data-management tools.

EXPERIENCE:

Bachelor's degree in Clinical Research, Healthcare Administration, Finance, Business Administration, Health Informatics, or a related field required.

Minimum of five (5) years of progressively responsible experience in clinical research administration, Coverage Analysis, clinical research billing compliance, research finance, budget development, financial review, or related research operations activities.

Experience reviewing Coverage Analyses, sponsor budgets, research billing determinations, research finance activities, or related compliance functions strongly preferred.

Clinical research operations experience, including experience as a research coordinator, regulatory specialist, research administrator, or related research role preferred.

Experience working in an academic medical center, healthcare system, pharmaceutical company, contract research organization, or research environment preferred.

Equivalent combinations of education and experience may be considered.

SUPERVISORY RESPONSIBILITY:

None.

Pay Range:

EEO Statement:

Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.

Location:

Work Type:

Work Shift:

Daily Hours: 

Driving Required: