Coverage Analysis, Financial Quality Specialist

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Acts as the main quality reviewer for Coverage Analyses that facilitate the activation of clinical trials.

• Assesses Coverage Analyses for precision, consistency, integrity of billing designations, regulatory adherence, and conformity with study requirements.

• Compares Coverage Analyses with study protocols, event schedules, intake documents, Medicare coverage guidelines, institutional standards, and related study materials.

• Detects and addresses discrepancies among Coverage Analyses, internal budgets, sponsor budgets, and study documentation.

• Coordinates necessary corrections with vendors, study teams, and relevant stakeholders.

• Performs quality reviews of negotiated sponsor budgets prior to approval by investigators or departments.

• Confirms negotiated budget terms, calculations, institutional fees, pass-through expenses, and sponsor payment obligations.

• Ensures consistency among final negotiated sponsor budgets, internal budgets, and validated Coverage Analyses.

• Reviews participant compensation structures, reimbursement models, and budget-related protocol amendments.

• Engages in CCRM intake meetings to highlight financial, billing, operational, participant compensation, and payer responsibility aspects.

• Aids in study activation by guaranteeing that essential Coverage Analyses, budget quality, participant compensation, and financial quality reviews are finalized.

• Offers billing compliance guidance and cross-coverage support for research billing review activities.

• Assists in investigating and resolving research billing discrepancies and compliance issues.

• Monitors quality review outcomes, billing review patterns, and recurring issue trends.

• Formulates recommendations for process enhancement, training, and risk mitigation.

• Upholds standard operating procedures, guidance documents, training materials, and review tools.

• Delivers education and training on Coverage Analysis, research billing compliance, participant compensation, and financial quality review.

• Participates in workgroups, quality improvement projects, workflow redesigns, operational enhancements, internal audits, and quality assurance initiatives.

• Maintains documentation and acts as a liaison with external vendors regarding quality-related issues.

⛳️ Requirements

• Extensive knowledge of clinical research operations, Coverage Analysis methodology, clinical research billing compliance, sponsor budget formulation, research finance principles, and study activation processes.

• Familiarity with Medicare coverage guidelines, qualifying clinical trial prerequisites, participant compensation methodologies, clinical trial agreements, and clinical research financial operations.

• Proven ability to analyze complex research documents, identify inconsistencies, evaluate risks, and propose practical solutions.

• Exceptional analytical, organizational, and problem-solving capabilities.

• Capacity to independently handle multiple priorities while ensuring accuracy and meticulous attention to detail.

• Outstanding written and verbal communication skills.

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

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

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

• At least 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 in reviewing Coverage Analyses, sponsor budgets, research billing determinations, research finance tasks, or related compliance activities is strongly preferred.

• Background in clinical research operations, including roles as a research coordinator, regulatory specialist, research administrator, or similar positions is preferred.

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

• Equivalent combinations of education and experience may be considered.

🏝️ Benefits

• Comprehensive health insurance plans.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and growth.

• Collaborative work environment with a focus on innovation.