Juliana Quach

Associate Specialist, Clinical Research @Edwards Lifesciences

Perform in study start up activities which includes, but is not limited to, tracking site readiness, clinical trial sites communications, and preparation for site qualifications and site initiation visits. Site management and maintenance. Review and verify documentation required for audits to ensure GDP compliance, and compliance with Edwards internal SOPs and US/OUS regulations. Work alongside cross-functional teams to ensure streamline efficiency Assist with training of clinical trial documents (i.e, Protocol, Investigator Brochure, Master Informed Consent, Source Documents, etc.) Participate in any other tasks to support Clinical Operations and Operating Company as needed.