San Jose, California, United States
Manage clinical trials for phase I - IV with emphasis in women's health, cardiology, oncology, and device.
Prepare weekly data query and enrollment reports; Coordinate sponsor/CRO weekly meeting to provide site data updates Monitor internal data flow: query missing data and visits, monitor safety data and escalate events as needed Prepare sponsors’ audit: gathered financial disclosure, training documents, CAPAs, etc… Close out CAPAs: investigate and identify deviation; verify and validate corrective action; implement training plans and document the entire CAPA process Wrote study specific SOPs and managed Master File
Conducted sites qualification, initiation, interim-monitoring, and close-out visits. Worked closely with principal investigators, clinical research coordinators, and study staff to ensure smooth operation and documentation of trials including: assessing site performance, tracking study drug and other study-specific material shipments to/from sites. Safety Coordinator: Received, graded, and escalated all SAEs and AEs in a timely manner to necessary regulatory agencies; collected supporting documents and wrote follow-up reports. CRO training and management: worked with study monitors to schedule monitoring visits and collection of CRFs.
Managed and completed study for the portable Ventricular Assist Device (VAD) for the HeartMate Ensured appropriate monitoring of designated clinical trials for completeness and accuracy of data as well as compliance with U.S. Food & Drug Administration (FDA) or other Regulatory body regulations Negotiated budgets and contracts with study sites; Conducted study training or other formal training at site Conducted study initiations, monitoring, and close out visits for VAD study Prepared and maintained case report forms, informed consent and other specialized documents for clinical investigations