Sample interview questions: Can you describe your experience in managing and resolving protocol deviations and violations?
Sample answer:
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Effectively managed and resolved protocol deviations and violations throughout the course of multiple clinical research studies, ensuring compliance with regulatory guidelines, institutional policies, and study protocols.
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Demonstrated strong attention to detail and a proactive approach to identifying potential deviations and violations early on, enabling prompt action to minimize their impact on the study’s integrity and participant safety.
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Collaborated closely with clinical research coordinators, investigators, sponsors, and regulatory authorities to investigate deviations and violations, gather necessary documentation, and address any concerns raised.
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Conducted thorough root cause analyses to determine the underlying factors contributing to deviations and violations, and implemented corrective and preventive actions to prevent their recurrence.
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Developed and implemented a comprehensive protocol deviation and violation management plan, outlining clear procedures for reporting, investigating, and resolving deviations and violations, ensuring a consistent and standardized approach across all studies.<... Read full answer
Source: https://hireabo.com/job/2_3_11/Clinical%20Research%20Administrator