• Clinical Research Consultant with over 28 years of Pharmaceutical/Biotech experience including Phase I – III clinical trial development with direct involvement in multiple FDA/ICH submissions leading to six NDA approvals. • Extensive monitoring domestically and internationally, training and mentoring innumerable CRAs/Monitors in the field which lead to further training responsibilities with Study Teams and Management Teams. Presented at multiple Investigator's meetings including protocol review, creating videos for sites inter-rater reliability, clinical and psychometric assessment training, CRF/eCRF instructions, Serious Adverse Event Reporting, drug dispensing and accountability as well as GCPs. • Key contributor to the preparation of multiple Clinical Study Reports, Protocols, Informed Consents, IND Safety Updates, FDA/ICH submission documents. • Received extensive clinical training and clinical research development experience in the following therapeutic areas: CNS: Psychiatry- Depression, Post-Traumatic Stress Disorder, Weight Loss, Nicotine Addiction; Neurology- Alzheimer’s and Parkinson’s Disease(s), Stroke and Spinal Cord Injury; Respiratory: Allergy and Asthma, Endocrinology, Dermatology, Infectious Disease, Anemia in Dialysis, Cardiovascular, Oncology Diagnostics.

Highlights:

• Florida
• Pharmaceutical Research
• Monitoring
• Management
• Team Building