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.
- 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.