JOB SUMMARY:
The SrCRA role is responsible for supporting monitoring and site management activities for the client Sponsored studies. Site monitoring and site management activities are conducted according to ICH GCP, applicable country/local regulations and client SOPs. Site interactions are conducted both on-site and off-site with documented interactions recorded in CTMS. The role involves collaboration with cross-functional clinical study teams and investigator site personnel to ensure study deliverables are met efficiently and effectively. The SrCRA is also responsible for the oversight of activities carried out at investigator sites where the monitoring may be supported by a CRO partner through the review of operational data and metrics.
KEY RESPONSIBILITIES:
Site Management and Monitoring Activities:
Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs.
Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely.
Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements
Oversight Monitoring:
Documentation and Reporting:
Issue Management and Escalation:
Collaboration and Communication:
Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.
Inspection Readiness
JOB REQUIREMENTS:
Education:
Bachelor's degree (or equivalent)
Experience:
Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA).
Skills:
Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories.
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