Naidu Kamisetti

Worked as a contractor for Bayer AG as a Study Manager do Phase I Studies

Regulatory Submissions (incl. MOH, IRB/IEC and local regulatory authorities) DraftingTrial specifc plans and templates CRA with in-house as well as on site monitoring responsibilities in the indications of Infectious Diseases/Urology, Cardiology and Oncology. Experience in US as well as EU trials. Responsibilities include -Investigator selection -Site and investigator compliance -Conduct of clinical trials -Main line of communication between Sponsor and Investigator

Clinical Research Associate with the following duties: • Proof reading Clinical study protocols • IRB protocol submissions and the IRB phases • Obtaining, reviewing, and processing regulatory and administrative documents from investigator sites • Monitoring investigator sites for GCP compliance according to the company SOPs • Plausibility checks in the filled out CRF forms • Source Data Verification at investigational sites • Authoring Clinical Study Reports

A Professional Training course for becoming a succesful CRA. The course is a practice oriented course taught by eminent people from the Clinical Research industry. The course covers several building blocks like ICH-GCP guidelines, AMG (German Medicinal guidelines), Medical and Pharmacological Basics, Medical Products, Biometry to name a few.

Worked in an EU mouse Embryonic Stem cell consortium "FunGenES", differentiation of Cardiomyocytes and their enrichment using Transgenics.

Tutored M.Sc and B.Sc Students practicals, taught and Counselled students about Bio-perspectives.