2. • Receive, record, and review FDA filing documents for accuracy and completeness and
submit to Sponsor for site activation into clinical trial(s)
• Guide sites in maintenance of regulatory documentation throughout trial(s) to accurately
reflect ongoing activities of participating sites and personnel
• Communicate with Principal Investigators and Research Coordinators providing remote
monitoring support to ensure site compliance with clinical trial protocol procedures
• Troubleshoot site issues in accordance with broad understanding of the assigned clinical
trial
• Maintain databases to track regulatory documentation, contract information and trial
wide communication efforts
• Assist with organization of meetings and investigator trainings, including preparation of
study aids and Manuals of Operation to ensure all materials updated and distributed to
participating hospital sites in cohesion with regulatory requirements
PRIVATE RESIDENCE – Henry Cohen & Family, Queens, NY 2001 – 2005
Health & Nursing Aid
• Assured all prescribed medication was accessed in a timely fashion.
• Responsible for filing healthcare and insurance documents.
• Prepared weekly finance records and detailed wellbeing summary; tracked mental health
• Progress and Clinical Trial with Cancer Patient for 3 years.
COLONIAL LIFE INSURANCE, Port of Spain, Trinidad 1997 2001
Executive Secretary/ Head Cashier, Finance Department
• Coordinated and supervised the training of new Life Insurance Sales Representatives
Education
• Clinical Research Academy of America Edison, New Jersey Diploma
• Business Analysis Certificate
• ASA Institute College of Advanced Technology –Brooklyn, NY Certificate for
Medical Billing & Coding
• Announcers Broadcasting Academy – Port of Spain, Trinidad – Diploma
• Business Administrative College – Port of Spain, Trinidad Certificate
• Caliber Training Institute of Manhattan, NY, NY Bank Teller Training – Diploma
Skills
• Excellent interpersonal skills and office etiquette.
• Strong analytical and organizational skills.Business Analysis
• Microsoft proficient (Word, Excel, Outlook and PowerPoint)