Lalitha Uppada

Fostered strong sponsor relationships, achieving high satisfaction scores and contributing to retention and repeat business. Led global project start-up phases, ensuring adherence to timelines, budgets, and quality standards while guiding regulatory and ethical requirements. Managed risk strategies to optimize site activation and timely delivery.

Led Phase I-IV clinical trials, overseeing site management, regulatory submissions, and study drug logistics. Supervised cross-functional teams, drafted study-specific informed consents, and managed CRO/Vendor selection and operational activities. Ensured compliance with ICH/GCP and SOPs, performing quality control checks and managing CAPAs.

Managed recruitment, screening, enrollment, and follow-up of study participants under the Principal Investigator's supervision. Coordinated direct patient care, including study visits and adverse event collection, while ensuring adherence to study protocols, SOPs, and FDA regulations. Handled EDC entry, query resolution, and auditing of source documents for monitoring visits.

Managed daily trial-related tasks, including scope definition and resource allocation, for endocrinology and autoimmune studies. Coordinated patient care, managed data collection and query resolution, and ensured compliance with SOPs, GCP, ICH, and FDA guidelines. Developed enrollment strategies and research materials, contributing to milestone achievements.

Facilitated clinical research by collecting and analyzing data, aiding budget preparation, and ensuring participant confidentiality and safety. Monitored compliance with GCP, ICH, and FDA regulations, and handled IRB submissions, regulatory documents, and deviation notifications. Supported initiation, conduct, and close-out activities to meet clinical milestones.

Engaged in neuroscientific research, designing experiments and utilizing molecular techniques. Served as a Teaching Assistant, instructing students in laboratory methodologies and molecular biology. Coordinated regular meetings with Principal Investigators and physicians, ensuring compliance with lab procedures and clinical protocols.

Activities and societies: Conducted neuroscientific research, designed experiments, and utilized molecular techniques. Served as a Teaching Assistant, instructing students in laboratory methodologies and molecular biology. Led a clinical research study from protocol development to review board presentation and presented research papers at state and national levels.

Pursued advanced medical studies focusing on clinical microbiology, immunology, and infectious diseases. Gained expertise in diagnosing and treating complex infectious conditions.

Completed foundational medical education, gaining comprehensive knowledge in various medical disciplines. Prepared for clinical practice and further specialization in the healthcare field.