Vacancy Description
Our Client, a Pharmaceutical company, is looking for a Clinical Research Associate 3 for their Durham, NC location. Responsibilities:
+ Serve as the sponsor-side point of contact for assigned sites, providing direct oversight of site performance, protocol execution, and overall study conduct throughout the trial lifecycle.
+ Conduct on-site and remote monitoring activities for Phase 1 oncology studies, including site qualification, initiation, routine monitoring, and closeout visits, in alignment with the monitoring plan, sponsor SOPs, ICH/GCP, and applicable regulations.
+ Provide sponsor oversight of critical study processes, including informed consent, eligibility confirmation, treatment administration, dose-escalation decisions, safety reporting, investigational product handling, protocol deviations, and data quality.
+ Evaluate site performance, operational readiness, and quality trends using monitoring observations, study metrics, and ...
+ Serve as the sponsor-side point of contact for assigned sites, providing direct oversight of site performance, protocol execution, and overall study conduct throughout the trial lifecycle.
+ Conduct on-site and remote monitoring activities for Phase 1 oncology studies, including site qualification, initiation, routine monitoring, and closeout visits, in alignment with the monitoring plan, sponsor SOPs, ICH/GCP, and applicable regulations.
+ Provide sponsor oversight of critical study processes, including informed consent, eligibility confirmation, treatment administration, dose-escalation decisions, safety reporting, investigational product handling, protocol deviations, and data quality.
+ Evaluate site performance, operational readiness, and quality trends using monitoring observations, study metrics, and ...
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