Clinical Research Associate II

São Paulo, Brazil

Full Time

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Key Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of st...