Experience

International Genomics Consortium

• Biotechnology Research
• 1 - 100 Employee

• Clinical Outreach Manager Regulatory Manager

  • Jan 2004 - Present

  Manage tumor tissue collection sites for the expO Tissue Collection Network to include regulatory compliance, training, tissue collection, clinical data submission and data quality. Monitor licensing, accrediting and regulatory agencies for any changes to compliance regulations to ensure continuous compliance. Coordinate external regulatory audits (CAP, CLIA, OSHA, etc) and ensure corrective actions are submitted and implemented. Manage company-wide document control functions to ensure maintenance of up-to-date policies, procedures, forms, training materials and other documents. Coordinate internal quarterly Quality Assurance audits for process control and improvement as well as staff competency.