Clinical Research Associate
• Functioned as sponsor Clinical Trial Manager contact for global Phase II gastric oncologystudy. Managed start-up activities including Informed Consent Forms (ICFs);study progress and timelines; investigator selection and activation; study plans,documents, templates, and training materials; and tracked vendor and site budgetand contracts.• Trained investigators and site staff on study Protocol and Pharmacy Manual duringSite Initiation Visits. Conducted Protocol training for Clinical Research Organization(CRO) and vendors for all amendments as appropriate.• Participated in user acceptance testing and implementation of Interactive WebResponse System (IWRS) and Electronic Data Capture (EDC).• Developed study templates, forms, and plans required for patient prescreeningthrough study completion, vendor management, and sponsor oversight.• Collaborated with Drug Safety with launch of the in-house safety database.