Experience

Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• CRA

  • Nov 2012 - Present

  ⦁ Ensured site conducted Clinical Trials according to Protocol, GCP and FDA regulations. ⦁ Took immediate actions to resolve queries and to prevent protocol deviations from re-occurring ⦁ Performed source document verification and ensured the collection of credible data for phase II/III/ trials ⦁ Ensured that SAEs, AEs and protocol deviations were documented and reported in accordance with FDA and SOP guidelines. ⦁ Ensured the maintenance of a complete regulatory binder and TMF according to the FDA/GCP guidelines. ⦁ Conducted Pre-study site evaluation, site initiation and routine monitoring at each assigned study site, as outlined in the Global Monitoring Plan (GMP)