Tirumala Devi Gonepalli

Background

About Tirumala Devi Gonepalli

Energetic and detail-oriented Clinical Research Coordinator with a Master of Science in Pharmacology and Toxicology and a Bachelor of Science in Pharmacy. I bring hands-on experience coordinating Phase 2 and 3 clinical trials across therapeutic areas including cardiovascular health, neurology, and behavioral health. With a solid foundation in patient recruitment, eligibility screening, informed consent, and protocol adherence, I am well-versed in ICH-GCP, FDA, HIPAA, and IRB regulations. My expertise includes managing investigational product (IP), reporting AEs/SAEs, and ensuring data integrity using EDC systems such as REDCap, SyMetric, and Clintrak. I have served as both blinded and unblinded coordinator, handling regulatory documentation, temperature logs, sample processing (IATA standards), and source data verification. I excel at collaborating with investigators, sponsors, and monitors to maintain site readiness and support audits. Known for my strong communication, multitasking, and organizational skills, I thrive in fast-paced clinical environments and am passionate about contributing to evidence-based medicine and advancing patient care through high-quality clinical research.