ICON plc - Homebased since Feb 2013
Sr. Clinical Research Associate
inVentiv Health Clinical - Homebased Apr 2010 - Jan 2013
Regional Clinical Research Associate II
inVentiv Health Clinical - Greater Philadelphia Area Apr 2009 - Apr 2010
Clinical Research Asssociate
PPD - Wilmington, North Carolina Area Apr 2007 - Oct 2008
Clinial Research Associate
Comair - Cincinnati Area Jul 2004 - Apr 2007
Internal Evaluation Auditor
Education:
University of Phoenix 2011 - 2015
Doctoral Student, Health Administration
Keller Graduate School of Management of DeVry University 2006 - 2007
Master of Project Management (MPM), Project Management
University of Phoenix 2003 - 2006
Bachelor of Science (BS), Business Administration
Pace University-Pleasantville/Briarcliff Campus 1986 - 1988
Skills:
Regulatory Affairs Clinical Research Project Management Clinical Trials GCP FDA Pharmaceutical Industry CRO CTMS Regulatory Submissions Clinical Development FDA GMP PERT TQM Quality Auditing Earned Value Management Business Process Management Medical Device Directive Quality Assurance Medical Devices GMP Clinical Monitoring EDC ICH-GCP Therapeutic Areas Clinical Data Management Protocol Sop Oracle Clinical 21 CFR Part 11 Infectious Diseases Clinical Operations Regulatory Requirements Patient Recruitment CAPA IND IRB Trial Management Rheumatology ICH guidelines Training Inform Quality System R ISO 13485
Interests:
Operations Research, Program Management, Program Development, Project Management, Business Process Management, Quality Assurance, Quality Auditing, Clinical Quality Assurance, Clinical Research, Medical Devices, New Product Development, Operations Management, Regulatory Affairs.
Keller Graduate School of Management of Devry University Dec 2007
Masters, Project Management
University of Phoenix Jul 2006
Bachelors, Bachelor of Business Administration, Bachelor of Science, Business Administration, Business
James Hillhouse High School Jun 1986
Institute For Operations Research and Management Sciences
University of Phoenix
Pace University
Skills:
Recalls Market Delaware Psi Iso Prostate Oab Infectious Diseases Clinical Research Medidata Regulatory Affairs Mentoring Product Complaints Cascade Sbc Business Administration Closeout Protocol Las Vegas Adhd Dispositions Clinical Development Treatment Clinical Operations Design Female Transparent 21 Cfr Part 11 Allocations Initiation Gap Site Initiation Human Resources Site Visits Skin Resurfacing Volunteering System Education International Standards Strategies Medicine Oncology Risk Management Drug Development Supplemental Calculations Part 820 Documentation Project Management Ind Renal Withdrawals Communication Negotiation Efficacy Project Bidding Ring Active Scientific Safety Quantity Renovation Indicators Facilities Management Hip Healthcare Management Responsibility Project Teams Usa Injection Molding Policies and Procedures Regulations Product Lines International Cro Mammography Class Ii Data Management Ulcerative Colitis Start Ups Guidelines Performance Plans Oracle Clinical Corporate Headquarters Lenses Nintex Compliance Canada In Vitro Hypertrophy Clinical Supplies Therapeutic Area Antiviral Wellbeing Connecticut Risk Directions Gastrointestinal Fda Kidney Disease Crf Design Overseeing Inform Phase Ii Federal Regulations Finance Medical Records End Stage Renal Disease Clinical Monitoring Location Intelligence Regulatory Compliance At&T Tqm Travel Procurement Float Pain Management Ctm Hitachi Calls Corporate Actions Tpp Metrics Cqa Auditing Iec Citizenship Approvals Yag Informed Consent Listings Eto Guidance Earned Value Management Entry Project Leadership Reports Cgp Qsit Public Health Testing Gcp Business Process Development Fda Gmp Part Time Transducers Mitigation Research Budget Constraints System Monitoring Investigation Trackers Inspection Raps Solo Frequency Operations Research Training/Mentoring Selecting Fix Protocol Data Collection Adolescents Iv Regulatory Risk Quality Assurance Validity Bladder Subject Matter Experts New Hires Timelines Omissions Distribution Center Operations Cost Control Metric Expired Knee Osha Presentations Pricing Therapists Site Identification Marketing Materials Patient Recruitment History Curriculum Design Milestone Resolve Issues Process Improvement Materials Performance Reviews Business Process Management Pmi Delays Cash Hemodialysis Internal Controls Interviews Theory Libraries Pharmacodynamics Budgets Registrations Amendments Evaluation Coordinated Databases Compare Ich Gcp Surgery Vendors Ctms Translation Compliance Testing Sep Ira Pma Program Evaluation Deviations Quality Auditing Ultrasound Developmental Organizational Structure Closure Florida Pulse Delta Feasibility Studies Crohn's Science Security Hiv Sop Bph Stem Defense Face To Face Faa Gmp Dosing Manuals Dissemination of Information Utilization Cra Management Strategy Supervision Genitourinary Microsoft Office Attainment Process Control Variable Microsoft Excel Transportation Trending Open Communication Customer Service Professional Development Seminars Status Reports Hernia Repair Delegate Scheduling American Stakeholders Chronic Kidney Disease Radiation Analysis Surveillance Letters R Etl Harmonization Rights Evaluations Complaint Management Applications Data Analysis Clinical Research Associates Regulatory Requirements Author Quality System Icf Eye Surgery Microsoft Project Project Pert Contractual Agreements Automobile Conflict Medical Imaging Case Report Forms Interstitial Cystitis Iso 13485 Class Iii Internal Audit Iron Certificate Number Phoenix X Ray Tmf Assistive Technology Trial Management Interfaces Forms Irb Reviews Escalation Process Pharmacovigilance Subjects Certified Trainer Moderate Contingency Abdominal Delivery Disposal Bands Employee Benefits Pharmacokinetics Constructive Feedback Clinical Trials Corrective Actions General Administration Health Management Redcine X On Site Clinical Data Management Safety Management Systems Change Control Oversight Site Management Pharmaceutical Product Development Arthritis Programming Savings Charting Batch Processing Japan Assessment Disease Edc Probes Task Completion Management File Systems Therapeutic Areas Icon Fortran Chain Clinical Practices Monitors Ethics Execution Theory of Constraints Justification Legal Writing Business Services Encouragement Cell Asset Allocation Client Requirements Medical Device Directive Budgeting Pv Training Point of Contact Patient Root Cause Materials Management Regulatory Submissions Quality Control Reporting Accounts Payable Capa Steam Concepts Sterilization Design Control Manage Budgets Rheumatoid Arthritis Project Plans Schedules Home Clinical Study Design Evidence Blind Operations Clinical Data Osteoarthritis Degrees Interactive Advertising Social Influence Dfu Measurements House Supports Engagement Rheumatology Paper Grammar Cras Sfp Dentistry Mpm Conflicts Art Cataract Executive Management Laser Iata Electronics Ich Guidelines Psychosocial Kentucky Bonus Medical Devices Software Annual Reports Phase Complaint Investigations Agents Business Process Manufacturing Dental Products Pharmaceutical Industry Meetings Interventions Eva Veeva Coordinate
Interests:
Operations Research Health New Product Development Clinical Research Regulatory Affairs Education Science and Technology Medical Devices Quality Assurance Human Rights Business Process Management Operations Management Civil Rights and Social Action Program Management Quality Auditing Program Development Project Management Clinical Quality Assurance Animal Welfare Arts and Culture
Languages:
English
Certifications:
Certified Quality Auditor Clinical Monitoring Foundations Introduction To Quality Engineering Internal Auditing For Fda Regulated Industries Design Controls: the Fda and Iso Atos Overview Good Monitoring Practices For Medical Devices