Perform study site visits (SQV, SIV, IMV, COV), ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements, generating monitoring trip reports, and track resolution of action items. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), selection and training of investigator sites, planning and running study meetings, evaluation, selection, and training of new study investigators.