Responsible for the oversight and management of quality and safety initiatives at a 1,070 bed acute, behavioral health and long-term care facility. Leads project teams utilizing Lean tools (e.g., flowcharts, fishbone diagrams), key performance indicators, and action plans to ensure sustainable improved outcomes. Drafts annual organizational Quality/Performance Improvement Program Plan and Failure Mode Effect Analysis (FMEA)/Proactive Risk Assessment. Provides education to staff, physicians, and leadership on high reliability organization (HRO) principles, Culture of Safety, Lean Six Sigma methodology and continuous regulatory readiness. Orients all new hospital staff and physicians on quality & safety initiatives throughout the organization and best practices. Develops educational tools and resources to improve required regulatory documentation compliance (CMS, NJ DOH, TJC) for physicians, nurses, and social workers. Presents results of performance improvement initiatives, hospital value-based purchasing reports, and other publicly reported metrics to hospital leadership with identified interventions for improvement. Responsible for the management of the Ongoing Professional Practice Evaluation (OPPE) indicators for 200 practitioners.

Provided support and implemented process improvement strategies to enhance experience, quality, and safety throughout the Medical Center. Coordinated hospital quality metric analysis, core measure abstraction, and improvement activities. Maintained supporting documentation of adherence to regulatory requirements.

Coordinated multiple Phase II/Phase III clinical trial research activities in compliance with federal, sponsor, and institutional regulatory guidelines regarding human subject research. Supervised and managed daily activities of clinical research team consisting of physicians, research assistants, and research support staff. Certified that equipment, supplies, and investigational products were properly maintained to establish patient safety and clinical research integrity.

Provided organizational, administrative, and clinical assistance for investigational clinical trials and a program evaluation study. Performed research study visits in accordance with protocol and institutional procedures, including vital sign assessment and collection of adverse event information. Recruited potential study subjects via self-developed advertisement materials and conducted pre- screening procedures to determine study subject’s eligibility per protocol-specific inclusion/exclusion criteria.

Designed and tested patient- and clinician-reported outcome measures through qualitative and psychometric evaluation studies to support pharmaceutical drug labeling claims. Developed regulatory dossiers and briefing documents for submission to Regulatory Agencies (FDA). Conducted in-depth qualitative concept elicitation, cognitive debriefing, and mode of administration equivalency interviews with patients, clinicians, and caregivers. Contributed to the development of publications including abstracts, manuscripts, and poster presentations. Trained incoming Research Associates on qualitative data analysis coding software and qualitative data saturation analyses