Main Responsibilities
The Central Monitoring Specialist is responsible for the execution of key Central Monitoring (Site, subject & study level review as applicable) activities and in assisting the execution of several key activities.
The Central Monitoring Specialist collaborates with the study team to execute Central Monitoring and comply with the applicable plans for the study.
Central Monitoring Specialist conducts review of the applicable Informatics platform and communicates findings at the country, study, site, subject level. He/she is responsible for the conduct of central monitoring activities in a timely manner and reporting, recommending changes in risk profile, and escalation as appropriate.
He/she may conduct risk assessments, review risk indicators, recommend mitigations to project teams.
Deep dive into identifying site & subject level risk in non-contributing RI which may overall affect the study level risk.
Qualifications(Minimum Required):
• University / college degree from an appropriately accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
• Minimum of 6 years of relevant clinical research experience in a pharmaceutical company/CRO or other equivalent experience with increasing levels of responsibility in clinical trial related roles e.g., project management, clinical monitoring, data management and informatics.
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