Quality Assurance

After my tenure as a study coordinator and in-house CRA, I joined Naurex as a Clinical Quality Assurance Technical Specialist, where I worked for nearly two years. At Naurex, my role involved conducting both internal and external audits, updating the clinical development standard operating procedures (SOPs), and overseeing training. However, the acquisition of Naurex's leading compounds by Allergan marked a shift in my responsibilities. I became tasked with ensuring the Trial Master Files (TMFs) for the two acquired compounds were comprehensive. This duty necessitated coordination with the clinical monitoring team, subject matter experts, and the internal QA team to verify that the TMF contained all necessary documentation to be deemed complete.