Estee Mo

Clinical Research Associate Ii @Pavmed Inc

US

Identify, evaluate, and establish clinical study sites.• Conduct regular site monitoring visits (virtually and physically) and prepare reports for study initiation, monitoring, and close-out visits.• Draft and/or provide input into Clinical Study Protocols, supporting plans, and procedures, including Informed Consent Forms (ICFs), Monitoring Plans, and Data Collection Forms in conjunction with the assigned Project Team.• Assist with Institutional Review Board (IRB) submissions.• Manage study budget and agreements with study sites.• Manage study Trial Master Files.• Train site staff on protocol requirements, source documentation, and case report form completion.• Serve as point of contact with study sites during IVD medical device studies.• Attending regularly scheduled teleconference meetings with clients during study preparation and throughout studies.• Monitor and analyze clinical study data and report on performance both internally and with study sponsors.• Assist with the development of study databases for managing clinical data.

Ambrose Alli University

Bachelor of Science - BS, Architectural and Building Sciences/Technology