SUMMARY OF QUALIFICATIONS * Strong knowledge of Site leadership and development of study protocols. * 12 years as Executive Director of the Airway Research and Clinical Trials. * 28 years' experience in Environmental and Employee Safety in the University and private sector. * Experience in laboratory and cleanroom equipment layout and ventilation design at the University and private sector. * Expertise in allergy and pulmonary medicine and clinical medical research. * Provided leadership for clinical research studies. * Assisted with and or wrote protocols, Protocol/Study Procedures Manuals, a built clinic infrastructure with the goal of FDA compliance. * Writing and editing Consent, Investigator Brochures and SOP Implementations * Significant knowledge of regulatory requirements and ICH guidelines. * Fifteen years of clinical research as a Staff Research Associate, a strong medical foundation and a variety of transferable skills. Knowledge of therapeutic areas include: Internal Medicine, Allergy and Adult Pulmonary. * Excellent written, verbal and interpersonal communication skills Comfortable speaking with RNs, MDs, study coordinators and clinic directors. * Professional experience has provided exposure to: drug development process, clinical monitoring processes, collaborative opportunities, compliance, training, data collection, source documentation, validation, personnel management. * Supervise and manage internal and external personnel to ensure timely initiation and completion of clinical studies and various clinical documents including those submitted to regulatory agencies
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