JobMesh

Lead Clinical Research Associate

PSI CRO · CA

Company Description PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and inno...

Job description

Company Description PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description: - Coordinates investigator/ site feasibility and identification process, as well as study startup. - Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. - Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. - Manages Monitors in the query resolution process, including Central Monitoring observations. - Coordinates safety information flow and protocol/process deviation reporting. - Performs clinical supplies management with vendors on a country and regional level. - Ensures study-specific and corporate tracking systems are updated in a timely manner. - Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. - Coordinates planning of supervised monitoring visits and conducts the visits. - Mana...