A phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pimavanserin for the treatment of irritability associated with Autism Spectrum Disorder (ASD). The study aims to understand whether pimavanserin, a highly selective antipsychotic, can safely and effectively treat irritability associated with ASD in children and adolescents.

As a site coordinator I managed the daily operations at Cortica from scheduling and running visits to data entry, management, and audits. Throughout, I maintained continuous dialogue with the study sponsor, principal investigator, site staff, and participants, while ensuring compliance with confidentiality agreements, Good Clinical Practices, and both FDA and IRB regulations. 

Study visits consisted of completing a range of rating scales, assessments, and medical procedures administered by the PI and/or the site coordinator. My visit responsibilities included managing appointment structures, recording vitals, performing ECGs, answering any procedure or protocol related questions, and various other duties.