National Institutes of Health (NIH) certified professional with comprehensive Clinical Research experience, extensive knowledge of Scientific Investigative Methodologies, and adept ability to comprehend drug therapy techniques in Clinical Research Trials. Astute leader of successful Clinical Operations and Teams comprising of numerous departments, in conducting Phase I through IV, bearing no compromise in meeting / exceeding quality, Protocol adherence and Regulatory Compliance. Technical knowledge of Electronic Data Capture (InForm, IMedidata-RAVE) and IVRS/IWRS. Clinical Research Fields: Dermatology, Cardiology, Gynecology, Endocrinology, Metabolic Diseases, Weight Loss, ENT, Vaccinations, Healthy Blood Draws, Oncology, Infectious Diseases, Gastroenterology, Pediatrics, Orthopedics, Rheumatology, Urogenital Disorders, Sexual Disorders, and Nephrology.Areas of Expertise include: Clinical Staff Leadership/Management Operations Management Quality Assurance/Control Clinical Assessment Protocol Pharmacokinetics (PK) Sampling   Clinical Trials/Research Source Documents Patient Recruitment   Audits & Reporting Regulatory Documentation FDA / GCP Compliance