Sr. Clinical Research Associate - Ophthalmology; CRA 16 years experience in clinical trials; device studies and pharmaceutical drug studies. Monitoring clinical trials according to Sponsor Protocols, Code of Federal Regulations and ICH Guidelines. Experience in monitoring the following therapeutic areas: Intra-operative wavefront laser for cataract surgery, IOL's, retina, diabetic macular edema, dry eye, contact lenses, ocular anterior segment, ocular allergies, vaccine trials, and osteo-arthritis. Data Handling - Experience in source data verification according to contractual requirements. Timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Timely and accurate completion of Data Clarification Forms. Proficient with multiple data capture systems.Field Monitoring - Strong site management experience and in all types of site visits; compliance with sponsor protocol requirements; timely reporting on Adverse Events (AE's) Serious Adverse Events (SAE's) and protocol violations; ensure proper storage, dispensation, and accountability of all IP, Investigational Product(s) and trial-related materials; regular reviews on status of the contents of the site regulatory binder and effective time management skills and site communication. Reporting and Tracking - Timely completion on IMV reports according to SOP or Sponsor requirements and thorough documentation and tracking the resolution of all outstanding site-specific protocol-related issues.