20/20, Addis Ababa University (CRO), Addis Ababa, Ethiopia, March 2005 to July 2006 Senior Clinical Research Associate - Opthalmology Studies, National Blindness, Low-Vision & Trachoma * Oversaw $3.5M study across 14 regional states to explore blindness, low-vision, and trachoma demonstrated sharp organizational skills in managing team of clinical data managers verifying data, and performing systematic networking of database for analysis and interpretation. Lead monitor (CRA) recruited, trained, and supervised 96 ophthalmologist (investigators), ophthalmic nurses, and district supervisors in 179 clinical study sites. * Reviewed and developed study specific, protocols, CRFs, ICFs, other essential regulatory tools. * Traveling to the study sites, directed 17 CRA's in site monitoring to ensure clinical trial validity and patient safety through training and consulting in site identification, site initiation, routine monitoring and close outs in accordance with CRO's SOP, FDA and ICH/GCP guidelines. * Mentored CRAs by conducting co-monitoring visits, reviewed monitoring visit reports and CRA responses to quality assurance audits, evaluated the quality and integrity of study site practices, identified inconsistencies and inefficiencies in processes and provided solutions. Tracked projects metrics to certify trial progress with trial activity milestones (TAM's). Reported detailed, timely co-monitoring study progress reports and ensuring corrective action. * Liaison clinical investigator team, Ethical committee, FDA, sponsor (Ministry of Health).

Highlights:

• Clinical Research
• Research
• Protocol
• Collection
• Critical Care - Neurology
• Management
• Neurology
• Oncology
• Quality
• Quality Assurance