•Establish and maintain good working relationships with the site investigational staff made sure each site adhered to the following: GCP, ICH, and FDA guidelines with their clinical protocol as well as the subjects rights and safety•Served as primary liaison as well as the main support for the trial between site investigators, project coordinators, and the IRB•Conducted site initiation and Site close-out visits through a virtual portal•Some experience in routine monitoring visits•Data collection, documentation, entry and reporting•CRF source document verification with ECRF•Query resolution with investigational sites•Maintained, updated and reviewed study files •Monitored enrollment at sites as well as providing recruitment strategies•Motivated site staff to reach enrollment goals as well as accurate and timely documentation•Reviewed Investigator files to verify all information was up to date as well complied with FDA guidelines•Identified and evaluated potential sites for new trial start ups•Ensure timely and accurate documentation and communication of study progress.•Monitor protocol deviations throughout trial conduct.•Experience in Phase 3 and Phase 4 trials as well as experience in Ophthalmology, Women’s Health, Men’s Health

•Coauthored 2009 Business Plan•Preparation of presentations for potential business partners•Creation of organization charts and business flow charts•Designed and created a database for maintenance of company’s financial and credit statements

•Designed and created proof of concept as well as prototype ECRF database•CRF database design was based on a hardcopy CRF that included 1200 field of data per patient•Data Entry made sure all the data was accurate and followed the guidelines of the clinical trial•Made copies of the CRF and source documents were stored in a secure and accessible location that was only available to approved study personnel •Helped analyze data for an Abstract of the study•Maintain MS Access database including production, validation and cleaning up database.