Clinical Research Associate
CurrentConducted on-going site monitoring visits to ensure compliance to study protocol and adherence to Experienced with FDA and IRB requirements.Reviewed source documentation, case report forms and data for patient inclusion and accuracy.Prepared and provided accurate and timely site monitoring reports.Trained monitors for Core and Adjunct Study site monitoring.Enrolled Investigators and assisted them in obtaining IRB coverage.Corresponded with Investigators and study coordinators to resolve study issues.Conducted site study close out visits.Responsible for Investigators compliance with FDA Regulations and Study protocolsEnforced the regulations and protocols, when necessary, by placing Investigators on suspension or termination of their Investigator privileges.
