I manage all aspects of clinical development and data collection; I am responsible for oversight of adverse event reporting, safety responsibilities, monitoring, adherence to protocols and determining study completion. The Director of Clinical I am a direct contact with Sponsors and CROs dealing with budgets and contracts.I am ensured that clinical trial projects are properly managed and executed withinin accordance with established timelines and quality standards per Protocol.I manage all the start up process for the Protocols, Regulatory Submission (such as annual reports, updating of the IB, and final study reports for assigned protocols) and other documentation required for conduct of a clinical trial. I manage the day-to-day clinical trials, including coordination of activities.I ensure all staff is well trained and ready to participate during a study.I participate in investigator meetings and follow up. I coordinate and plan for the availability of our Physician and Staff to meet Monitor assigned per study.I maintain proper communications with CROs and Sponsors to ensure communication and goodrelationships in connection with matters related to clinical trial projects.

Monitoring and Management complex studies involving adult and pediatric patients on pivotal Phase 1 to 3 investigational studies and open label extension studies in the following therapeutic areas: Endocrinology (Diabetes), Immunology (Rheumatoid Arthritis), Infectious Diseases (HCV, skin Infections), Neurology (Alzheimer), Neuro-Psychiatry (Autism), Ophthalmology (Macular Degeneration), Pediatric (sJIA and PcJIA), Psychiatry (Schizophrenia, OCD) and Respiratory (Asthma/COPD).

Managed multiple trials in immunology within adult and pediatric population. Served as an EDC trainer regionally. Mentored junior level CRAs and served as a resource for new employees.Received ongoing excellent customer satisfaction scores. Utilized my skills in a creative way to reach the study’s goals and milestones.

Monitored and Managed Oncology complex studies involving patients on Phase I to III investigational studies and open label extension studies in the following areas: Colorectal and Prostate Cancer.Managed multiple clinical trials across various therapeutic areas in early and late phase drug development.