Sampath Kunduru

Background

About Sampath Kunduru

Healthcare professional with over 4 years of clinical research experience, specializing in the coordination and support of Phase studies. Proficient in eTMF (Veeva Vault) and Paper Trial Master File, electronic data capture (EDC), Vendor managementand CTMS databases (VEEVA & IMPACT). Clinical Research Coordination: Expertise in study startup processes, TMF setup, site selection, and management of vendor contracts, budgets, and RFP/vendor proposals. Documentation & Data Management: Skilled in receipt, review, filing, and retrieval of TMF documents, resolving queries, data collection, documentation, entry, and reporting. Regulatory Compliance: Knowledgeable in US FDA regulations and ICH GCP guidelines, ensuring regulatory documents are accurately tracked and distributed throughout the clinical trial lifecycle. Study Initiation & Close-Out: Experienced in preparing study startup documents, managing site approvals, drug accountability logs, and conducting site close-out activities. Quality Assurance: Maintains and reviews eTMF and site files with a focus on quality assurance. Collaboration & Communication: Strong communication skills for effective teamwork and collaboration with CROs and third-party vendors, ensuring successful study execution. Technical Skills: Proficient in MS Word, Excel, PowerPoint, Outlook, SharePoint, and familiar with DIA TMF Reference and study start-up activities. Multitasking & Organization: Capable of managing multiple tasks with attention to detail and assisting in various clinical study projects.