Senior Clinical Research Associate

The Senior Clinical Research Associate will conduct site monitoring responsibilities for clinical trials, providing oversight and leadership to ensure compliance and quality. This includes performing qualification, initiation, interim, and close-out visits, reviewing monitoring reports, ensuring protocol compliance, and verifying data integrity through source document review. Responsibilities also encompass investigator site visits, coordinating with cross-functional departments, assisting with study-specific plans and ethics documents, managing study budgets for stand-alone projects, and ensuring compliance with ICH GCP guidelines, FDA regulations, and company SOPs. The role involves mentoring new CRAs, contributing to CTMS development, facilitating adverse event reporting, and resolving data discrepancies.