Company Description

At Milestone One, our mission is to bring clinical trials to much wider populations of sites and patients around the world. For too long, clinical trials have only been available to a handful of patients at a handful of hospitals - a unique opportunity for selected few. Imagine every patient with no hope of a cure having the option of getting access to clinical research enabled by their physician and hospital.

Founded by a team of seasoned professionals with more than 30-years of global industry experience, we bring together driven and dedicated people around the world, working collectively to help make a positive impact on patient lives. Milestone One partners with research sites to navigate the complexities of clinical trials seamlessly. From medical equipment rental services to patient support services, we provide end-to-end support tailored to each site’s unique needs empowering them to focus on what truly matters — delivering innovative therapies to patients. 

Outstanding quality is at the heart of Milestone One. We hire only the best professionals on the market: experienced, engaged, open for development. Not only excellent specialists but also reliable and supportive team mates – we care not only about our clients but also about our team!

Job Description

We are seeking an experienced Clinical Research Billing Specialist to join our Site Enabling Organization (SEO). This role is critical for ensuring accurate and compliant billing of clinical research activities from the site side, with particular attention to differentiating between research-related services and standard of care (SOC) services. The ideal candidate will have deep expertise in clinical trial financial operations, research billing compliance, and a thorough understanding of standard of care (SOC) billing practices. You will ensure proper invoicing of clinical trial services in accordance with contracts, while maintaining regulatory compliance.

Key Responsibilities:

Billing Management: Oversee and manage billing processes for clinical research activities at the site, ensuring accurate billing of research-related services to sponsors and proper consideration related to site billing of standard of care (SOC) services to third-party payers (e.g., Medicare, private insurers).Budget Review & Development:Work with site staff, sponsors, and clinical research coordinators to review and negotiate clinical trial budgets, utilizes the research fee schedule to develop the per patient and pass through budgets for those billable items and services which cannot be billed to third party payers. Ensures that all costs and effort to conduct the study are appropriately covered within the study budget.Thoroughly reviews complex study protocols, Informed Consent Documents, draft sponsor Clinical Trial Agreements , and budgets to identify all billable items and services required of the study which might generate a CPT code. Documents the CPT codes at the respective visits for all billable items and services to be paid by the grant.Compliance Monitoring: Ensure all billing activities align with regulatory guidelines, including federal and state laws regarding clinical trial billing, Medicare regulations, and ethical billing practices.Invoice Generation & Reconciliation: Create and issue invoices to sponsors for research-related services per clinical trial agreements.Financial Reporting: Prepare detailed financial reports on billing activities, accounts receivable, and payment reconciliation for internal stakeholders and sponsors. Provide guidance to stakeholders to help them drive compliance with SOC requirements.Site Support: Provide training and guidance to research sites on distinguishing and appropriately billing standard of care services versus research-related services. Assist sites in understanding clinical trial agreements, budgets, and billing procedures.Data Management: Maintain accurate and organized financial records related to clinical trials in the billing system, ensuring that all research-related services are clearly tracked and documented.

QualificationsEducation: Bachelor’s degree in finance, healthcare administration, or related field. Equivalent work experience may be considered.Experience:3+ years of experience in clinical research billing, revenue cycle management, or financial operations within a healthcare or clinical research setting.Expertise in differentiating between standard of care (SOC) services and research-related services.Strong knowledge of clinical trial budgeting, billing processes, clinical processes, medical terminology, clinical research life cycle, and research compliance, including Medicare Coverage Analysis (MCA).Skills:Excellent understanding of clinical trial financials, particularly in managing SOC billing vs. research billing.Proficiency in financial management systems and billing software (e.g., CTMS, QuickBooks, SAP, etc.).Strong organizational, analytical, and problem-solving skills.Ability to communicate effectively with internal teams, site personnel, sponsors, and CROs.Personal Attributes:Highly detail-oriented with a focus on compliance and accuracy.Strong organizational skills with the ability to manage multiple projects and deadlines.Self-motivated, able to work independently and in collaboration with cross-functional teams.

Additional Information

This role is essential in ensuring compliance with clinical trial billing regulations, expertise in understanding standard of care vs. research-related costs, driving financial accuracy, and advancing medical research.