michael leon rn resume 2015
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Michael Leon, R.N., MBA, CCRC, Kissimmee, FL 34746-6068 Page 1 of 3 02/09/15
(407) 572-5729, [email protected]
MICHAEL LEON, R.N., MBA, CCRC
KISSIMMEE, FL 34746(407) 572-5729 EMAIL: [email protected] SUMMARY Registered Nurse with 23-year record of continuous professional growth and superior skill sets. Command Level Flight Nurse USAF, Level 1 Trauma veteran (ORMC/NYC), talented team leader/member. Experienced providing nursing care in austere and combat environments. Operational and Program Leader able to ensure sustained superior outcomes. PROFESSIONAL EXPERIENCE Consultant, Site Selection and Feasibility 2015-2015
OnPoint CRO, LLC http://rxtrialsinc.com/ Home Based, FL Contracted to identify clinical research sites for pre-selection and feasibility analysis for a complex oncology study
Developed extensive call list of 40+ research sites, initiated site contact, coordinated approval and completion of Confidentiality Disclosure Agreements, and ensured accomplishment of feasibility analysis by potential sites. Launched ~10 sites in 3 weeks
Director, Quality Assurance 2014-2014
Compass Research, LLC http://www.compassresearch.com/ Orlando, FL Managed and oversaw day-to-day operations of the Quality Assurance Department. Provides leadership, training,
guidance, and assists staff with assigned duties and responsibilities ensuring business operations run efficiently and smoothly
Supervises and performs quality assurance audits to include: clinical investigator sites, vendors, processes, systems, and document reviews
Assists and provides guidance to operations and information technology departments on all aspects of internal computerized systems including upgrades and configuration changes
Directs the development, implementation, and maintenance of Quality Management program activities and overall quality assurance systems
Accountable for the organization and effectiveness of quality assurance through management of operating principles, values, and behaviors
Assists with the development of reporting, tracking, and analysis of quality initiatives and trending of quality issues
Directs the management and implementation of company-wide SOPs and works collaboratively with operations management in the development of work instructions/guidelines
Assists operations in the facilitation of regulatory inspections and sponsor audits
Provides direction and guidance for deviations, investigations, and resolution for potential quality issues to improve efficiencies and quality functions
Supervises and supports the daily work direction of the quality assurance group
Acts as management level QA liaison with sponsors and other appropriate departments
Provides strategic input and leadership toward implementation of more efficient Quality Systems
Keeps company employees apprised of U.S. and international regulations, ICH GCP and other guidance
Oversees and coordinates the QA activities for programs/projects with responsibility for maintaining timelines with relationship to cost, methods, and resources
Directs and manages the preparation of QA documentation for internal and external reports
Director 2011-2014
RxTrials Inc. http://rxtrialsinc.com/ Ellicott City, MD Delivered sustained superior study performance to sponsors, and Contract Research Organizations (CRO)
Improved study outcomes 80% at 13 sites in a difficult to enroll inpatient study for a Global CRO
Recruited and evaluated potential clinical sites for participation in research studies Created the Quality Assurance/Quality Control program for a 25-site network and the consulting division. Optimized
productivity, ensured performance, and defined audit ready conduct of phase II-IV studies
Michael Leon, R.N., MBA, CCRC, Kissimmee, FL 34746-6068 Page 2 of 3 02/09/15
(407) 572-5729, [email protected]
Established the organizational overview, structural capacity, educational design processes, and quality outcomes for the Society for Clinical Research Sites (SCRS); awarded the title of Accredited Provider with Distinction through the American Nurses Credentialing Center
Cultivated Clinical Research Coordinators, Principal Investigators and Sub Investigators; produced exceptional research teams throughout the 25-site network
Launched the implementation of a new Clinical Trial Management System (CTMS) for the Network. Subject Matter Expert, Super-user, and trainer for >75 users; ensured a smooth transition to the new system
Director 2010 – 2011
Florida Pulmonary Research Institute http://fakihresearch.com/indextest.html Winter Park, FL Defined standard operating procedures, managed, and coordinated all clinical studies, doubled number of studies,
improved overall site performance 100%, and increased revenue projections by $1 million
Developed, negotiated, managed ~30 contracts and budgets increased annual revenue projection to >$2.5 million
Directed and oversaw the Institutional Review Board process, exceeded sites’ prior performance
Led and evaluated 16 personnel. Guided and cultivated a professional team environment
Campus Research Coordinator 2000 – 2010 Florida Hospital-Celebration Health Research Institute http://www.celebrationhealth.com/ Celebration, FL
Established/developed the clinical research program at the Celebration Health campus of Florida Hospital (FH)
Created campus components to support clinical research; secured a preeminence within the FH system
Led, managed and coordinated all aspects of >100 Phase I-IV sponsored and investigator initiated studies
Generated clinical trial opportunities, developed, negotiated, and managed study and department budgets
Institutional liaison/resource person regarding clinical studies at the 172-bed campus and 8-campus level
Led department personnel; developed team to obtain ACRP certification of 7 RN Clinical Research Coordinators Major U.S. Air Force Reserve 1994 – 2013
45Aeromedical Evacuation Squadron (AES) MacDill Air Force Base Tampa, FL Assistant Chief Nurse responsible for oversight of all assigned nursing personnel, 28-RN Flight Nurses, 60-Flight Medics
Officer In-Charge of Credentialing/Clinical Education; responsible for initial training, sustainment training, certification, and evaluation of clinical education for 28 flight nurses and 60 flight medics assigned to 45AES
Command Level Flight Nurse, senior crewmember of the aeromedical evacuation (AE) airlift team. Planned and prepared worldwide aeromedical evacuation missions, supervised team and coordinated with airlift crews
Administered in-flight patient care and emergency care to >2000 patients
Leader, Director, essential AE expert to >13 personnel within a Mobile Aeromedical Staging Facility (MASF). Assigned duties and evaluated team performance. Led, planned, and coordinated field operations during combat operations in austere environments. Responsible for >$900k in medical equipment and assets
Medical Intelligence Officer; provided essential medical intelligence reports to unit Commander and unit personnel ensuring worldwide deployment readiness
Deployed in support of Operations: Enduring Freedom, Iraqi Freedom, Unified Response, Noble Eagle
Registered Professional Nurse 1998 – 2000
Celebration Health Emergency Department Celebration, FL Delivered quality care and outstanding customer service, to patients, families, physicians, and other contacts, while
accepting responsibility for maintaining relationships that were equally respectful to all
Registered Professional Nurse 1997 – 2000
Walt Disney World Health Services https://disneyworld.disney.go.com/ Lake Buena Vista, FL Provided First-Aid care for visiting guests. Occupational health nurse for Walt Disney employees
Registered Professional Nurse 1994 – 2000
Orlando Regional Medical Center Level 1 Trauma Center/Emergency Department Orlando, FL Provided trauma and/or emergency nursing care to patients of all ages and diverse ailments
Michael Leon, R.N., MBA, CCRC, Kissimmee, FL 34746-6068 Page 3 of 3 02/09/15
(407) 572-5729, [email protected]
Registered Professional Nurse 1992 – 1994
Bellevue Hospital Center Level 1 Trauma Center/Emergency Department NYC, NY Delivered initial and ongoing assessments, triage, and essential interventions to emergency patients
Flight Nurse 1993 – 1994
72nd Aeromedical Evacuation Squadron McGuire Air Force Base Wrightstown, New Jersey Flight Nurse, senior crewmember of the aeromedical evacuation (AE) airlift team
Technical Sergeant U.S. Air Force Reserve, In-flight Medical Service Specialist 1986 – 1993
72nd Aeromedical Evacuation Squadron McGuire Air Force Base Wrightstown, New Jersey Administered patient care in-flight. Deployed in support of Desert Shield & Desert Storm
EDUCATION University of Miami, Miami FL 2014 Collaborative Institutional Training Initiative RxTrials Institute, Ellicott City MD, 2012 Good Clinical Practice Course Department of Defense, Washington DC, 2009 Patient Safety Manager Course Randford University, Washington DC, 2006 Master of Business Administration – Healthcare Air University, Maxwell AFB AL, 2005 Flight Commanders Course Randford University, Washington DC, 2004 Bachelor of Science – Healthcare Air Education and Training Command, Sheppard AFB TX, 2004 Nursing Service Management Course Air University, Maxwell AFB AL, 2003 Squadron Officer School USAF School of Aerospace Medicine, Brooks AFB TX, 1997 Battlefield Nursing Course Armed Forces Medical Intelligence Center, Defense Intelligence Agency MD, 1996 Medical Intelligence Course Academy of Health Sciences at Fort Sam Houston TX, 1995 Combat Casualty Care Course USAF School Of Aerospace Medicine, Brooks AFB TX, 1993 Aeromedical Evacuation Flight Nurse Course Bellevue Hospital Center NYC Health and Hospitals Corp., 1993 Critical Care Nurse Internship Program College of Staten Island, City University of New York, 1992 Associate in Applied Science in Nursing Community College of the Air force, Maxwell AFB AL, 1991 Associate in Applied Science Allied Health Sciences
REFERENCES Professional references provided upon request