Leslie R. Smith

Dedicated and enthusiastic Clinical Operations Professional with experience in pivotal NDA and PMA trials. Strong communication skills, ability to interact effectively, good critical reasoning skills and rapid critical thinking skills by identifying issues and proactively determining solutions. Initiative-taking, flexible, positive attitude and able to work independently as well as part of a team. Thorough and in-depth understanding of Good Clinical Practice and Code of Federal Regulations. Therapeutic area: Drug Safety: HIV, Oncology, Vaccines Clinical Research Associate: Pharmaceuticals: CNS (Insomnia and migraines), female contraception, oncology and rare genetic disorder Devices: Vascular Sealant, female contraception, oncology (Breast cancer) and sinuplasty stent. Study phases: I, II, and III, Post Marketed and Registries. Companion Diagnostics: Systemic Lupus Erythematosus and Lupus Nephritis Types of Visits: Pre-Study, Site Initiation Visit/Investigator Meetings, Interim Monitoring visits and Close-out Visits. Highly experienced in clinical research management, with comprehensive knowledge of regulatory requirements and clinical trial operations. Strengths include strategic planning, project management, team leadership, and process improvement initiatives to enhance efficiency. Notable contributions include successful implementation of improvements in clinical trial protocols resulting in enhanced data accuracy and study performance. Results-driven Clinical Research Manager known for high productivity and efficient task completion. Possess specialized skills in clinical trial management, regulatory compliance, and data analysis. Excel in communication, leadership, and problem-solving to achieve project objectives on time and within budget. Efficient and focused professional in clinical research management. Known for high productivity and ability to complete tasks efficiently, ensuring timely project advancements. Skilled in patient recruitment strategies, regulatory compliance, and data analysis. Excel at communication, teamwork, and problem-solving to drive successful outcomes in complex research environments. Multi-talented clinical research professional proficient in handling patient information, laboratory samples, and compliance procedures for different clinical trials. Well-organized and hardworking with excellent communication and planning skills.

Certified Clinical Research Professional, Society of Clinical Research Associates, Los Angeles, CA, 01/01/06 - 12/31/08