Manages procedures and guidelines from different sponsors and/or monitoring environments ( FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. […]
Detailed tasks and responsibilities assigned to role are outlined in the task matrix.Essential Functions and Other Job Information: Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking...