Clinical Trial Associate/Senior Clinical Trial Associate

Support the Clinical Study Lead and Clinical Operations team in day-to-day operational activities to ensure study objectives, timelines, quality standards, and regulatory requirements are met. Oversee CROs, vendors, and investigator sites by reviewing monitoring visit reports, tracking site communications, and following up on study-related actions. Maintain study tracking tools for documentation such as Form FDA 1572, manage site activation, enrollment, and monitoring visit status, and support Trial Master File activities including document collection, filing, and inspection readiness. Prepare study agendas, minutes, and status reports while collaborating cross-functionally with Regulatory Affairs, Clinical Supplies, Data Management, and Safety teams. Manage study team training records, system access requests, and escalate risks or operational challenges as needed.