Aya Healthcare - Anaheim, CA
posted 3 months ago
The Clinical Research Budgets Analyst will be responsible for the timely and accurate preparation and maintenance of budget templates for sponsored clinical trials. This includes conducting a comparative review against budgets offered by study sponsors and setting up study payment milestones in the Clinical Trial Management System. The role requires a thorough review of New Study routing forms and essential study start-up documents, as well as performing itemized cost analysis and interpreting clinical protocols into budget milestones. Additionally, the analyst will provide accurate patient cost descriptions for the Informed Consent Form (ICF) to be submitted to the Institutional Review Board (IRB) and will update budget, milestones, and ICF information as necessary per contract or protocol amendments. The position involves close collaboration with the coverage analysis team, contract analysts, regulatory team, program managers, and internal finance groups. The analyst will manage a large volume of workflow across multiple research programs, each functioning differently. Key responsibilities include developing study budgets from clinical study protocols using various software tools, completing full evaluations and integrations of internal costs during the setup of new clinical studies, and revising study budgets following protocol revisions or reassessments of study costs. The analyst will also utilize and oversee research rate pricing for services rendered as part of clinical trials and communicate with Contracts Analysts to integrate study budget information into clinical trial agreements, potentially participating in the contract negotiation process. Furthermore, the analyst will independently initiate or update coverage determinations for each study as applicable and communicate specific study billing structures to clinical teams and service providers. They will participate in the administration of study-subject related billing as needed and provide support with auditing billing records. The role requires maintaining complete records and statistics on expenses and payments, regularly monitoring compliance with predetermined budget/billing plans and agreements, and establishing positive working relationships within the Office of Research Administration (ORA) and the research departments, as well as with other institutions involved in clinical research. The analyst will also be responsible for setting up study payment milestones and Billing Instructions grids using Microsoft Applications (Excel) and/or the Clinical Trial Management System, and providing support to individual physician investigators while developing internal cost analyses for investigator-initiated trials.