PAREXEL - Raleigh-Durham, North Carolina Area since Apr 2011
Clinical Monitoring Associate II (In House CRA)
Health Decisions Jan 2007 - Mar 2011
In-House CRA
Health Decisions Jan 2007 - Apr 2008
Clinical Trial Assistant
PPD Inc Aug 2005 - Dec 2006
Medical Communications Specialist
Education:
University of North Carolina at Chapel Hill 2008 - 2009
Certificate, Core Concepts of Public Health
North Carolina State University 1998 - 2003
BS - Animal Science
Skills:
Clinical Trials Clinical Monitoring Ctms Edc Clinical Research Cro Pharmaceutical Industry Fda Oracle Clinical Gcp Clinical Development Ich Gcp Protocol Therapeutic Areas Regulatory Affairs Sop Medical Devices Regulatory Requirements Oncology Infectious Diseases Clinical Data Management Medical Writing Data Management Inform Lifesciences Crf Design
Interests:
Coffee Travel Running In Addition To My Other Interests
Biomerieux
Senior Project Manager
Mallinckrodt Pharmaceuticals Jan 2013 - Sep 2013
Project Manager
Mallinckrodt Pharmaceuticals Jan 2011 - Dec 2012
Senior Project Engineer
Mallinckrodt Pharmaceuticals Feb 2008 - Dec 2010
Pmo and Cmms Supervisor
Mallinckrodt Pharmaceuticals Jan 2003 - Jan 2008
Plant Engineer
Education:
North Carolina State University 1990 - 1995
Bachelors, Chemical Engineering
Skills:
Lean Manufacturing Six Sigma Validation Fda V&V Gmp Manufacturing Capa Medical Devices 21 Cfr Part 11 Quality System Process Engineering Pharmaceutical Industry Sop Dmaic Change Control Root Cause Analysis 5S Biotechnology Continuous Improvement Technology Transfer Supply Chain Management Regulatory Affairs Minitab Project Management Process Simulation Iso 13485 Ms Project Product Development Fmea Design of Experiments Iso Process Improvement Quality Control Cross Functional Team Leadership R&D Quality Management Software Documentation Quality Assurance Engineering Kaizen Glp Business Process Improvement U.s. Food and Drug Administration