Description
PROFESSIONAL SUMMARY Clinical Research Professional with various project experience from concept to development. Talents include in-depth knowledge of ICH guidelines SAE reporting and GCP auditing. Integral team-player with excellent communication skills CORE QUALIFICATIONS * Patient Recruitment & Screening * Detailed Documentation * Serious Adverse Event Reporting * Communicating with IRB for study proposal, approval and updates * Create and update study documents such as FDA 1572, ICF etc in order to maintain regulatory compliance