Elizabeth (Betsy) Knight, Certified Clinical Research Associate (CRA), Senior CRA Manager, oversees KAI Research, Inc.’s CRA team and monitors numerous single- and multi-center studies in a variety of therapeutic areas and indications, including biologic and behavioral interventions.
She is responsible for clinical monitoring activities for pharmaceutical studies submitted to the Food and Drug Administration under investigational new drugs or new drug applications. Ms. Knight trains and initiates sites on new protocols, creates study documents and tools, monitors investigator performance, conducts site visits, and performs data quality assessments.
During site visits, Ms. Knight reviews regulatory documents and assesses patient eligibility, protocol compliance, data quality, investigational product/device compliance, and study performance. She meets with investigators and site staff to assess approaches for conducting the study and summarizes her visit in a report to the Project Officer/Sponsor. Additionally, she has 6 years’ experience in study coordination/site management in the field of neurology.
Before her current position with KAI, Ms. Knight worked in the pharmaceutical industry, beginning as a Senior Monitor and progressing to the position of Principal CRA/CRA Specialist. Prior to that, she worked for KAI for 5 years as a Senior CRA/Auditor for National Institutes of Health studies. Ms. Knight is a CRA certified by the Association of Clinical Research Professionals.