Mô tả công việc
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. 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. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
Yêu cầu kinh nghiệm
Performs and coordinates clinical monitoring and site management, ensuring protocol and regulatory compliance, audit readiness, and collaborative relationships with investigational sites.