Clinical Trials Auditor

Job Summary

To support the oversight of clinical trials, the part-time Clinical Trials Auditor will perform comprehensive audits and monitoring of investigator-initiated trials, ensuring protocol compliance and generating detailed reports on findings while working remotely.

Key responsibilities

• Conducts audits and monitoring visits to assess compliance with protocols, consent processes, and eligibility criteria
• Generates audit and monitoring reports summarizing deviations, discrepancies, and missing data
• Verifies timely reporting of Serious Adverse Events and protocol deviations to relevant regulatory and internal organizations

Required qualifications

• Bachelor's degree in biology, chemistry, biochemistry, physiology, nursing, or related fields
• Two or more years of experience as a Clinical Research Associate or clinical trial auditor/monitor
• Familiarity with regulatory requirements for clinical trials and adverse event reporting
• Experience in reviewing clinical trial protocols and amendments
• Ability to provide training and guidance to clinical research staff when necessary