Clinical Research Associate, Chicago, IL

I have been working in the Biotechnology industry for the last 9 years in the Pharmacokinetics & Drug Metabolism group at Amgen. I worked to characterize the pharmacokinetics (PK), pharmacokinetics/pharmacodynamics (PK/PD), and metabolic fate of novel drug candidates using state-of-the-art procedures and technologies. I supported discovery from research into the clinical. I developed and validated analytical methods which I used to analyze samples from research, GLP toxicology, and phase 1 clinical studies. I am very familiar with GLP, GCP, FDA and EMA regulations. I have had extensive internal and external GLP and FDA inspection training. I have been through multiple lab inspections as well as documentation audits. I have experience in successfully managing multiple projects to meet expected goals and timelines. I have project management and operational leadership skills for the creation of project documents; scope of work, timelines and budgets. I would like to switch gears a little and use what I have learned to become a clinical research associate.

Agricultural Technician