Clinical Trials Monitor/Auditor
Foundation
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $39 - $61 per hour
About the role
- Performs comprehensive audits and monitoring of City of Hope Investigator-initiated clinical trials conducted under a COH-sponsored IND or IDE and other high-risk protocols as necessary.
- Reviews internal regulatory documents, protocols, amendments, correspondence and serious adverse event reports.
- Performs extensive audits and monitoring visits to determine protocol compliance, including the consent process and eligibility criteria.
- Performs extensive review of case report forms and study data, utilizing medical records, laboratory data, transfusion services records, and any other source used to produce study data.
- Generates an audit report or monitoring report, summarizing the findings of all deviations, discrepancies, and incorrect or missing data.
Requirements
- Minimum Education: Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or other related fields.
- Minimum Experience: Two or more years of experience as an industry Clinical Research Associate or clinical trial auditor or monitor.
Benefits
- Comprehensive Benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial auditingprotocol compliancecase report form reviewdata analysismedical record reviewlaboratory data analysisadverse event reportingmonitoring visitsaudit report generationstudy data evaluation