Coverage Analysis and Financial Quality Secialist

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

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…