Gema Souto Adeva

Clinical Regulatory and Operations Specialist Ind Manager @National Institute Of Allergy And Infectious Diseases Niaid

Rockville, MD, US

Federal regulatory lead for the Office of Clinical Research Policy and Regulatory Operations (OCRPRO) in the Division of Clinical Research (DCR) at NIAID/NIH/HHS. o Point of contact for all regulatory related questions from the investigators/site staff, pharmacy, laboratory, manufacturing and other stakeholders. Manage the coordination of Investigational New Drug (IND) submissions in close coordination with various research offices and committees of the DCR, contractors and pharmaceutical companies responsible for pre-clinical screening and administrative collaboration with principal investigators responsible for clinical trial protocols. o Sponsor Authorized Representative (SAR) for a large portfolio of INDs. Responsible for the formal submission of all communications from and to the FDA on all active INDs as well as new INDs.Develop and maintain DCR policies and guidelines related to Regulatory Operations, Monitoring Activities, Safety Monitoring, and Protocol Navigation. Provide subject matter expert input to relevant sections of CRADAs executed for the conduct of OCRPRO sponsored IND studies.

Society of Clinical Research Associates

CCRP

University of Minnesota-Twin Cities

Bachelor's Science Degree

Duke University School of Medicine

Master's degree