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Quality Assurance and Oversight
• Conduct periodic quality assurance reviews of clinical research documentation, including source data,
case report forms, and regulatory files, to ensure GCP and institutional compliance.
• Identify findings, develop corrective and preventive action (CAPA) plans, and track resolution through
completion.
• Support readiness for sponsor, federal, and internal audits by maintaining accurate and complete
research documentation.
• Develop and deliver QA tools, checklists, and training resources for study teams and faculty.
OnCore CTMS Management
• Ensure data integrity and standardization across protocols, coordinating with research finance,
compliance, and departmental teams.
• Generate OnCore reports to support leadership oversight and operational decision-making.
Veeva eRegulatory System
• Oversee the maintenance of electronic regulatory binders in Veeva eRegulatory to ensure complete,
accurate, and compliant documentation.
• Conduct regular quality control checks of study regulatory files and assist in resolving discrepancies.
• Support and train faculty and staff in the use of Veeva for document submission, routing, and approval
workflows. IRB and Regulatory Compliance
• Liaise between the study team, IRB, and other institutional offices to ensure timely and compliant
submissions.
• Maintain awareness of current institutional, federal, and sponsor regulations impacting human subjects
research.
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