Began my career in clinical research in West Virginia working as a Clinical Research Associate with the CRO United Bio Source Corporation where I monitored sites and helped prepare sponsors for FDA audits. Prior to becoming a Research Manager, I worked as a Clinical Research Coordinator covering a wide variety of research areas including pediatric vaccines, adult vaccines and multi-therapeutic pharmaceutical trials. I am currently responsible for the implementation of clinical research studies for drugs and devices applicable to many therapeutic areas. This includes study execution and management, daily monitoring of Investigational site’s progress, strict protocol adherence, and drug and device accountability. I am also responsible for the management, preparation and submission of clinical documents for Investigational Review Board and Sponsor submissions ensuring all regulatory and IRB documentation are in adherence to FDA Regulations and ICH/GCP Guidelines.
Listed skills include Clinical Research, Clinical Trials, Regulatory Submissions, Ctms, and 5 others.