Sample interview questions: Can you explain any experience you have with monitoring and auditing research sites for compliance with study protocols?
Sample answer:
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Monitoring and Auditing Experience:
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Regularly conducted on-site monitoring visits to ensure adherence to study protocols, regulatory requirements, and ethical guidelines.
- Evaluated the integrity and completeness of study data, including source documentation, informed consent forms, and adverse event reports.
- Assessed the qualifications and training of research personnel, including investigators, coordinators, and data managers.
- Identified deviations from the study protocol, regulatory standards, or ethical principles, and took appropriate corrective action.
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Provided written reports of monitoring visits, highlighting findings, recommendations, and corrective actions taken.
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Ensuring Compliance:
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Developed and implemented monitoring and auditing plans tailored to the specific study design, objectives, and regulatory requirements.
- Collaborated with Principal Investigators (PIs), research staff, and sponsors to ensure a shared understanding of study protocols and compliance expectations.
- Conducted audits of study records, data collection procedures, and data management systems to verify accuracy and completeness.
- Reviewed case report forms, laboratory results, and other essential documents for consistency with study protocols and data collection guidelines.
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Identified and addressed potential risks or vulnerabilities that could compromise the integrity of study data or participant safety.
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Communication and Reporting:
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Effectively communicated monitoring and audit findings to PIs, research… Read full answer
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