OBJECTIVE: A position as a Clinical Research Associate.

Ability to perform all needed duties in a professional and courteous manner, together with strong tech nical training expertise and good communication skills adding value to your orga nization. SUMMARY: Over 3 years experience as a Clinical Research Associate specializing in diabet es. (Phase IIIII studies) More than 12 years experience in drug safety and clinical research in academic setting and pharmaceutical industry. Comprehensive working knowledge of FDA, regulatory regulations and guidelines r elated to clinical research. Knowledge of drug development processes. Highly organized with proven ability to deal with multiple assignments and meet deadlines. Willing to travel 70% of the time. EXPERIENCE: Biodel Inc. Danbury, CT Clinical Research Associate 2007 to Jan 2011

Conducted pre-study, initiation, monitoring and close out visits according to S OPs and GCPs Reviewed, collected and filed clinical trial documents after source documents v erification (SDV) Responsible for overall site management of assigned sites which included writte n and verbal communication and scheduling of monitoring visits Responsible for completion of visit reports and maintenance of study-related da tabases Participated in field monitoring training Maintained relationship between the site and the companys main office Communicated submitted paperwork to the therapeutic team Communicated with investigative sites on routine matters concerning the ongoing trial Handled requests for trial related information Attended weekly clinical meetings in office and remotely. Prepared clinical trial documents (e.g. investigator site file and monitoring g uidelines. Maintained an active liaison with members of other groups involved in the drug development process, particularly data management and also with the Clinical tri al team. Collaborated with clinical team on data/document collection and preparation for FDA auditing of sponsor Resolutions of DCFs upon re-opening of database Auditing of randomly selected clinical sites to assure quality assurance FDA site inspection preparation Maintained drug accountability at sites Collaborated in designing templates for drug accountability, protocol deviation logs, study monitor logs, etc Reviewed CRFs for corrections against source documents, New York Presbyterian Hospital Pharmacy/Weill Cornell Medical Center, NY, 20002007 The Rockefeller University Hospital Investigative Drug Services, New York, NY Pharmacy Research Assistant Responsible for drug study forecasting, ordering and tracking of investigationa l drugs; regulatory document filing & archiving.

Worked closely with the Clinical Study Managers and Clinical Data Manager to ma nage phase 1- 1V clinical trials. Responsible for overseeing on-site monitoring of clinical trials including prestudy, site initiation, interim, and close-out visits, while assuring adherence to Good Clinical Practices. Developed templates for study initiation deliverables (checklist for site evalu ation, initiation, monitoring, close-out; subject screening, recruitment and vis it logs, drug accountability logs) Demonstrate knowledge of GCP & ICH/FDA guidelines- CFR Title 21: demonstrates a n understanding of and complies with laws and regulations and standards governin g investigational drugs. Managed vaccine ordering and shipment process from IAVI (International Aids Vac cine Initiative) & Sanofi Pasteur. Demonstrates a working knowledge of procedures and operations relating to the m anufacturing, packaging and labeling of drug products. Experienced in studies conducted in Dermatology, Metabolic disorders & Endocrin ology disorders and HIV. Retrieval of patient medication reconciliation-list from patients chart along w ith list of concomitant meds and also doctors progress notes. Assisted the Senior-Pharmacist in charge when meeting with investigators, study monitors and others in coordinating study logistics (Start-up & closing out of studies) PROFESSIONAL DEVELOPMENT Computer Skills: Familiar with clinical trials EDC (electronic data capture) Micromedex/ LexiComp Online Drug Formulary (medical database) Horizon Meds Manager (pharmacy database) IAS ordering System (medical supplies) Certificate: Certified Clinical Research Professional, SoCRA September 2007 Human Participant Protections Education for Research Teams, NIH July 2007 The Role of Gastro protection in Patients on NSAID Therapy, ASHP August 2006 Training: Applied GCP- guidelines - ACRP November 2010

Monitoring guidelines - K-Force July 2010 SOPs- ACRP July 2010 ICH-GCP An overview - ACRP December 2009 SoCRA Clinical Research Workshop for Monitors, Philadelphia, PA May 2007 Human Participants Protection Education for Research Teams, CUNY NY July 2007 HIV/AIDS Therapy Training Rockefeller University Hospital, NY May 2007 EDUCATION: Bachelor of Science in General Sciences Long Island University, Brooklyn, New York June 1997 Arnold & Marie Schwartz School of Pharmacy and Health Sciences, PROFESSIONAL AFFILIATIONS: Member of Society of Clinical Research Associate, SoCRA Member of Association of Clinical Research P