April 18, 2014
As a field monitor I conduct prestudy, site initiation, interim and close-out visits. As an in-house CRA I manage investigational sites, oversee monitors, co-monitor the clinical studies. As an auditor, audit investigational sites, in-house clinical trial documents. Prepare investigational sites for FDA audits. Since 2007 active member of the Association of Clinical Research Professionals.
I would like to share my clinical research experience, such as investigator selection, site qualifications, protocol design, monitoring visits and reports. Share my experience having close working relations with regulatory and data-management. Share my experience to guide investigators to adhere to protocol and FDA regulations, guidelines, as well as their institution operating procedures.
I expect to learn new technologies, adopt to developing technologies and ethical standards.
I am a clinical research professional with 10+ years of experience in managing and overseeing a clinical investigation.