Responsibilities

The Senior Clinical Research Associate will conduct and coordinate all aspects of clinical monitoring and site management processes, including remote and on-site visits to assess protocol and regulatory compliance, manage required documentation, and ensure audit readiness. They will also serve as a site processes specialist, developing collaborative relationships with investigational sites, performing risk-based monitoring, conducting root cause analysis, and implementing corrective and preventive actions to maintain compliance and minimize risks. Additionally, the CRA will ensure data accuracy through reviews, document observations in reports, and bring up observed deficiencies to clinical management for resolution.