Occupation:Clinical Research |
Location:Upper Darby, PA |
Education Level:Bachelor |
Will Relocate:YES |
Description
SUMMARY OF QUALIFICATIONS * Industry Experience: Clinical Trial Coordination Health Outreach and Education and Management Regulatory Compliance (IRB, ICH, Good Clinical Practice). * Clinical Trial Experience in NIH and Industry-funded Phase I, II, III, and Post-Market device trials in the departments of Neurosurgery, Neurology, Stroke, Family Medicine, Emergency Medicine, Ob/Gyn and Podiatric Medicine. * Experience in setting-up the local Trial Master File (eTMF) and Investigator Site File * Significant experience as a Clinical Research Coordinator, managing aspects of Institutional Review Boards (IRB) research studies, including screening and recruiting subjects, securing clinical samples, all within regulatory guidelines. * Strong managerial abilities to perform daily operations, meet time sensitive deadlines, and build customer service relationships, supports and follow-through of protocol renewals. * As a Regulatory person ability to understand FDA regulations and follow all steps in the approval process. * Strong writing skills and a firm understanding of medical terms. Proficiency with extensive knowledge of softwares is a huge plus. Ability to effectively translate medical and scientific material, including biostatistics, so readers fully grasp complex terms, data, and medical processes. Researching is a required job skill, so familiarity with literature search, reputable medical journals and clinical research publications is my strength. * Patient Care Experience as a Consulting Physician at a Specialist Hospital in India and Kingdom of Saudi Arabia, primarily as a Gynecologist and Medical Consultant in Family Medicine, supervising nursing and paramedical staff, and day to day administration of a Health Center. CERTIFICATIONS/EXAMINATIONS * Educational Commission for Foreign Medical Graduates Certified (ECFMG) - Jun 2007 * U.S. Medical Licensing Examination (USMLE) Step 1 - Feb 2007 * U.S. Medical Licensing Examination (USMLE) Step 2 Clinical Skills - Apr 2007 * U.S. Medical Licensing Examination (USMLE) Step 2 Clinical Knowledge - Jan 2006 * Advanced Cardiac Life Support (ACLS) - Sept 2014 * Pediatric Advanced Life Support (PALS) - Sept 2014
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