• Manage all phases of clinical trials form regulatory start-up to study close-out.• Experience in the conduct of clinical research including ICH-GCP requirements.• Working knowledge of medical terminology, FDA regulations and ICH guidelines. • Provide extensive in-service training and supervision of research staff. • Maintain all study documentation including source documentation, electronic case report forms, study and regulatory binders and patient charts.• Facilitate timely completion of electronic case report forms and reporting of severe adverse event reports to the sponsor and IRB• Execute successful pharmaceutical sponsor audits for high enrolling studies

• Accelerated the growth of the research department• Acted as liaison between principle and sub-investigators and pharmaceutical companies for study-related correspondence• Facilitated sponsor and/or CRO site visits, correspondence and follow-up• Managed subject visit scheduling, subject visits and clinical trial data, formulating source documents and data collection charts and severe adverse event reporting. • Enhanced internal monitoring and quality improvement plan.• Recognized by physicians for attention to detail, patient advocacy and decision-making abilities in critical situations.

• Designed custom artwork for clients. • Facilitated pre press file preparation for color separation, working with all major desktop publishing, design and layout applications, to a direct-to-plate process. • Implemented Variable Data and Cross Media Marketing.