Core Competencies: Clinical Research Monitoring, Risk-Based Monitoring, IND/IDE Regulatory Oversight (FDA form 1571 and FDA form 1572), Research Compliance, Quality Assurance, Inspection Readiness, FDA Regulations, GCP, CAPA Management, Data Integrity, Clinical Research Operations, Staff Leadership, and Strategic Operations Management. Core Competencies: Clinical Research Monitoring, Risk-Based Monitoring, IND/IDE Regulatory Oversight, Research Compliance, Quality Assurance, Inspection Readiness, FDA Regulations, GCP, CAPA Management, Data Integrity, Clinical Research Operations, Staff Leadership, and Strategic Operations Management.