Clinical Trials Business Operations - Associate (FT), Clinical Trials Office

180002NZ Requisition #

Position Summary:

Assists with the completion of various tasks related to the initiation and administrative management of clinical trials. Develops Medicare Coverage Analyses (MCAs) for all clinical trials. 



  1. Perform Medicare Coverage Analyses for all studies, including entering the appropriate HCPCS and CDM codes for items and services to complete the Billing Grid and determining if conventional care items/services qualify for Medicare coverage. Works closely with other departments such as Revenue Management and Compliance and Auditing to accurately conduct, review, and implement Medicare Coverage Analyses.
  2. Coordinates with Research Teams to validate the study and patient data in the Registry and to ensure data is consistent with the Dartmouth Billing System and the IRB Database. Manages receipt of and upload all appropriate study related documents. 
  3. Conducts or reviews (or, as requested, assist research teams with the development and negotiation of) clinical trial study budgets to ensure these budgets are developed in accordance with Dartmouth approved information systems, tools and standards.
  4. Conducts a feasibility review with the research teams based on approved standards and guidelines.
  5. Participates in resource meetings with study teams to review the MCA, budget, other study documents, and to make conventional care determinations to complete the final draft of the MCA.
  6. Acts as the main study liaison for the CTO and coordinates with the IRB and other internal / external parties to ensure that all required approvals are received prior to study initiation. 
  7. Makes determinations on the segregation of items and services provided to research patients with the use of a Medicare Coverage Analysis billing grid and other medical documentation and ensures either the patient or the research account was billed appropriately for clinical trial related item and services.
  8. Acts as the primary CTO liaison to PI and research staff.
  9. Participates in the development of and makes periodic updates to Clinical Trials Business Operations policies and procedures.
  10. Trains or assist in training new Clinical Trial Business Office Associates to ensure uniformity and quality of work.
  11. Performs other duties as required or assigned.
Minimum Qualifications:
  • Bachelor’s degree with 2 years of experience in a healthcare or clinical setting with demonstrated knowledge of clinical trial billing compliance and pre-award activities required. 
  • Knowledge of coding preferred. 
  • Strong competency in Microsoft Excel and Word required. 
  • Knowledge of Velos preferred. 
  • Effective organizational skills with strong attention to detail. 
  • Effective interpersonal and communication skills desired.
Required Licensure/Certification Skills:
  • None

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