Lead Clinical Research Associate with 10 years actively managing overall site quality, awareness of study progress, site staff training and establishing efficient feedback system to mitigate risks has resulted in proper subject care, evaluable data and audit readiness recognized by Sponsors. Performed Lead CRA duties for Phase l-lV clinical trials. Conducted Dose Observation Visits, Site Initiation, Routine Monitoring and Close Out Visits. Types of clinical trial experience: Rare diseases, Pediatric, Device, First in Man, Vaccine, Genitourinary, Hepatology, Neurology, Nephrology, Endocrinology, Infectious Disease, Cardiometabolic, Dermatology, Immunology, Pulmonary and Oncology in healthy, pediatric, geriatric, mild to severe medical condition patient populations. Providing Project Team support by timely communications and escalation. Showcasing leadership through developing and implementing quality management plans for site staff when solving problems. Special attention to detail during source document review and verification. Participating in continuing education, training and review of Sponsor resources to remain current on all policies and regulations. Adherence to ICH-GCP, local / federal regulations and protocol specific requirements for duration of clinical trial.