About

Ms. Caravella is the Director of Regulatory Affairs for the UNC Institute for Global Health and Infectious Diseases and serves as the Regulatory and Ethics Consultant for the International Core of the UNC CFAR. She has an MPH in Epidemiology and Biostatistics from Boston University and a BA from Duke University. She has 20 years of experience working in the pharmaceutical industry and in academic medical centers. Currently, Ms. Caravella oversees the regulatory affairs for 400 studies worldwide, providing support with both international and domestic IRBs, and works with other regulatory authorities including the FDA and equivalent bodies in collaborating countries. She assists investigators and sponsors in the regulatory approval process, provides GCP and Human Subjects Protection training for staff, and serves as a resource for sound ethical research in human subjects. She has worked with researchers in 10 countries such as Malawi, Zambia, Vietnam, South Africa, Cameroon, China, and Russia.