Clinical Research Associate
CurrentSupported the clinical project team throughout assigned study projects.• Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IR approvals, contracts, protocols, etc.)• Accurately update and maintain clinical systems within project timelines.• Prepared, handled, distributed, filed, and archived clinical documentation and reports.• Reviewed study files periodically for accuracy and completeness for quality audits.• Prepared, handled, and distributed Clinical Trial supplies and maintenance of tracking information.• Performed reviews of Informed Consents (ICF), subject documentation and other regulated documents for Institutional Review Board (IRB) approval.• Tracked and managed Case Report Forms (CRF), queries and clinical data flow.