CRA2 - Multi-Sponsor Department

Conduct site monitoring visits for selection, initiation, monitoring, and close-out in adherence to Good Clinical Practice and ICH guidelines. Adapt and track subject recruitment plans with investigative sites while administering protocol training and establishing communication channels. Evaluate site practices for protocol conduct and regulatory adherence, escalating quality issues as needed. Manage study progress by tracking regulatory submissions, enrollment, case report form completion, and data query resolution. Maintain Trial Master File and Investigator's Site File documentation, submitting regular visit reports and follow-up letters. Collaborate with study team members for project execution support.