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SUMMARY OF PROFESSIONAL EXPERIENCE Regulatory, Quality, Clinical and Compliance Medical Executive with major milestones/achievements in the Life Science Industry. Over 30 years in Class III and Class II devices/allograft/biologics, inside/outside the United States (OUS) primarily in the fields of cardiology, cardiovascular, neurology, spine and orthopedics. Integral involvement with 80+ product categories. Personally prepar...
Tags for this Online Resume: Medical Device, Regulatory/Quality, Clinical, Audit, Distribution, Budgeting, Microsoft Windows CE, Advertising, Cardiovascular, Compliance, clinical, trial, protocol, ich, FIM, EFS, gcp
Summary of Specialized Skills * Design, development and conduct of device based Clinical and Pre-Clinical Research projects. * Experience in writing various clinical documents, including protocols, CERs, reports, research findings. * Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies. * Management of scientific/animal studies and clinical projects. * Hands-on exper...
I am pursuing a role in the Clinical or Regulatory Affairs group as a specialist. I was a manager but I would prefer to be an individual contributor in either department.
Summary Senior CRA with regulatory submission responsibilities, worked in CRO at local level within single/multicentric Clinical Trials (phase 1-3 and Bioavailability Studies) and coordinating all process: feasibility studies, sites identification, contracts negotiations with PI/hospital administration, collection of documents and CT dossier preparation, submission to Regulatory Agencies, preparation/submission of Amendment...
part-time work-at-home clinical data entry
I am a project/administrative coordinator with 4 years experience in hospital administration and close to 15 years of overall Healthcare experience including document specialist and medical transcriptionist.
Recent CWRU graduate - MA in Bioethics, Clinical Research Concentration. Experienced Regulatory Affairs/Compliance Specialist (FDA, DOI, NIH, OIG, OSHA). Extensive knowledge of IRB processes, including SpartaIRB Protocol. Assisted in several CWRU IRB quality improvement and review processes. Proficient in education/training methods and electronic presentations. Extensive experience writing and monitoring policies and proce...