st. vincent hospital Cancer Care
• Supervise, coordinate and manage oncology clinical trial program for community and private practice physicians. Program includes: 72 clinical trials (brain, breast, cervical, colon, endometrial, glioblastoma, head and neck, ovarian, and renal) approximately 300 patients and 14 clinical trial staff positions, and 2 private practices and 1 community – more... practice.
• Reviewed and documented assessments of patient care program and progress. Assessed and document adverse events, reviewed protocols and communicated patient clinical care directions/options to attending physicians.
• Supervised the provision of data and clinical updates to insurance companies to appeal coverage requests. Assessed and provided clinical patient specific data.
• Define and implement strategy to oversee regulatory, safety and clinical compliance programs.
• Supervise and conduct forensic audit of entire cancer care clinical trial program (1999 to present) to identify compliance risks, deviations and violations.
• Create and execute risk management program to identify and address operational, patient safety, data management, and privacy risks within organization. Define risks, document action plans and track data to ensure risks and regulatory/safety expectations are managed. Implement tools to improve productivity/efficiency.
• Created and implemented policies and procedures to incorporate FDA regulations and ICH Guidelines to analyze and measure improvements and document risks. Define roles/responsibilities, re-train staff, proposed CAPAs to sponsors and document/publish success measures.
• Organized, tracked and published compliance and efficacy data for Ascension Health System. Monitored effects of program throughout system. – less