Clinical Operations
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Experienced healthcare and clinical research professional with expertise in acute care, private practice operations, and advanced clinical research management. Proficient in protocol development, regulatory compliance, and process optimization, achieving measurable improvements in operational efficiency and quality assurance. Proven leader with a history of successfully managing clinical trials, implementing EMR systems, and transitioning organizations through acquisitions and restructuring.
Experienced clinical research and healthcare operations professional with over 25 years of success leading clinical trials, regulatory submissions, and organizational turnarounds. Demonstrated expertise in protocol development, regulatory strategy (including 510(k), EUA, IVDR, and de novo), and EMR implementation across both private practice and CRO settings. Known for improving operational efficiency, achieving regulatory compliance, and driving financial recovery through strategic planning and team leadership.
Proven ability to manage transitions during acquisitions and restructuring, while mentoring cross-functional teams and fostering innovation.
Certified ACRP-CP, MDP, and PM, with a strong foundation in both acute care and advanced research environments.
