Обязанности и достижения:
Coordinated and performed in-house monitoring activities as related to the conduct of the clinical trials; participated in conducting site visits as a part of clinical team. Provided services for the collection, review, maintenance, and tracking of regulatory documentation: 1572s, ICFs, monitoring reports, PIs Signatures, PDs in CIMS and Central Files for Phase III studies, ensuring compliance with FDA regulations as related to GCP guidelines, and Company Standard Operating Procedures (SOPs).