SUMMARY OF QUALIFICATIONS Diverse professional with over 10 years of Clinical Research, with a wide background and range of therapeutic areas. A full understanding of Pharmaceutical, Regulatory Compliance, Quality Assurance and Quality control According to the FDA standards, GCP and all Regulatory Compliance. Demonstrated excellent Analytical and Troubleshooting skills in the highly technological fast-paced Research and Clinical trial environment. The ability to prioritize and organize various projects concurrently without compromise to detail or quality of data. Customer-oriented, team builder and mentor with strong interpersonal, communication and leadership skills. RESEARCH EXPertise * Demonstrated strengths in Project Management, Site Monitoring, Clinical Trial Monitoring, Regulatory Compliance, Clinical Research Methodology, Detailed understanding on AE's and SAE's. Standard Operating Procedures (SOP), Good Clinical Practice (GCP), IATA, Masterscope, Writing Consents, Contributing to Protocols and timelines, Phlebotomy and eCase Report Forms. Contribute to Publications and Study outcomes. * Therapeutic areas include Infectious Disease, Oncology, Type 2 Diabetes, Hypertension, Atopic Dermatitis, Chronic Obstructive Pulmonary Disease, Asthma, Female studies, Medical Devices, Pulmonary Fibrosis and PET Imaging. Excellent interpersonal skills. Solid ability to translate technical information and provide training to Study Team. Clinical Data Management Systems: InForm, Oracle RDC, eCinical, Red Cap, Informatics and Rave.

Highlights:

• Compliance
• Protocol
• Pharmaceutical
• Research
• Management
• Clinical Research
• Document Review
• Pharmaceutical Research
• Data Management
• Radiologist