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

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Page 1: Michael Leon RN Resume 2015

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

Page 2: Michael Leon RN Resume 2015

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

Page 3: Michael Leon RN Resume 2015

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