Experienced and certified clinical research professional with years of expertise in study design, protocol development, and regulatory compliance. Proven ability to effectively coordinate study trial, analyze data, and prioritize patient safety. Possesses a strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes, accompanied by exceptional problem-solving and communication skills. Demonstrated track record of successfully coordinating and conducting clinical trials, including expertise in TMF management, IRB activities, subject recruitment, and adverse event reporting. Proficient in utilizing EDC tools and experienced in all aspects of data collection, validation, and analysis. Committed to advancing medical knowledge and enhancing patient outcomes. Highly results-oriented with a solid background in health research and proficient database management. Adept in statistical analysis, and SAS software, ensuring meticulous attention to detail and maintaining the accuracy and integrity of medical data. Exceptional interpersonal and communication skills, fostering effective collaboration within interdisciplinary teams and consistently meeting project deadlines.
Member, Association of Clinical Research Professional (ACRP), 2023