Katie Barrett has 8 years of experience in the clinical operations field. Katie began their career in 2009 as a Clinical Project Associate at Molecular Insight Pharmaceuticals, where they developed supportive study documents for 3 phase II clinical studies, prepared pre-study document packages for distribution to study sites, and managed the procurement and preparation of study supplies. In 2010, they worked as a Study File Analyst at Pfizer Pharmaceuticals, where they conducted a complex review of regulatory documents for accuracy according to FDA and ICH guidelines, verified required documents were filed properly within the electronic Document Management System, and ensured all study and site documents were filed within electronic Document Management System for multiple studies in preparation for upcoming inspection. Katie then moved to Antisoma as a Clinical Project Associate, where they supported the tracking of study timelines and undertook a regular review of these documents, ensured compliance with SOP and GCP requirements on all clinical study related activities, and conducted complex review of regulatory documents for assurance of quality and accuracy. In 2011, they worked as an In house CRA at EMD Serono. In 2012, they worked as a Sr. CTA at FORUM Pharmaceuticals and a Sr. Clinical Trial Coordinator at Biogen Idec. In 2014, they worked as a ClinOps at Medivector Inc. Finally, in 2015, they worked as an Associate Director of Clinical Operations and ClinOps at AZTherapies, Inc.
Katie Barrett attended the University of New Hampshire, where they earned a Bachelor of Science in Medical Lab Sciences.
January, 2021 - present
January, 2015