Profile Accomplished and highly skilled clinical research associate employs a successful international track record in clinical environments, is experienced monitoring multiple site locations, clinical site evaluation, initiation, maintenance and close out visits in accordance with GCP and company SOPs. Ensures integrity of study data and study timelines, utilizes excellent understanding of ICH/GCP guidelines, applicable regulations, and monitoring practices that ensure quality data and superior site management. * Well-developed nursing, patient care and administration expertise with strong knowledge of therapeutic areas including Allergy and Respiratory, Cardiovascular, Metabolic and Endocrine Diseases, Gastrointestinal and Hepatology, Genitourinary/Sexual Health, Infectious Diseases, Inflammation, Neuroscience, Oncology, Ophthalmology and Pain. * Serves as a Project Manager, Assistant Auditor and Senior CRA on multiple projects with strong knowledge of Clinical Trials Management from extensive experience with TEVA Neuroscience, IVAX Research, several Clinical Research Organizations (CRO) and the U.S. Army. * First hand professional exposure to drug development and clinical monitoring processes provides collaboration, compliance, training, source documentation, validation, and project and personnel management opportunities. * Research experience provides strong ability to analyze, gather, write, evaluate and produce detailed reports on a variety of projects, is adept at training, education and knowledge of Regulatory Affairs (FDA guidelines) GCP and ICH guidelines * Utilizes a strong medical foundation and a variety of transferable skills from ten years of military nursing experience is comfortable working with RNs, MDs, Study Coordinators and Clinic Directors.
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