Description
Summary of Qualifications Clinical Research Manager, Associate, Monitor, Coordinator, with over 25 years experience in the medical field and 21 years experience in clinical trials with extensive experience in the fields of Cardiology, Electrophysiology, Neurology, Urology, Autoimmune, Respiratory, Gastroenterology, Weight Loss, Diabetes, Women's Studies, Arthritis, COPD, Gynecology, Endocrinology, Rheumatology and Stem Cells. Expertise covers all aspects of clinical research coordination with inpatient and outpatient protocols, in addition to in-house and regional Clinical Research Associate and Monitoring duties. My responsibilities as a Clinical Research Manager, Associate and Monitor include participation in a team environment while performing the typical tasks of these positions. Including preparation of clinical protocols and regulatory submissions, implementing clinical studies and providing support for the studies with clinical and technical guidance throughout all study phases. As well as, performing essential functions of development of study documentation, site selection, site initiation, monitoring and close out, provision of technical and clinical guidance during procedures, support database management aspects with direct involvement from data entry and interfacing with statistician to the development of database software platforms. In addition to coordination and implementation of investigator meetings and preparation of materials to support regulatory submissions for U.S. and International commercialization, identification and generation of pertinent reports involved with the clinical studies and other various projects. Experience provides coordination of multiple complex General Cardiology, Interventional Cardiology, Cardiac Arrhythmic, Neurologic, Urologic, Gynecologic, and Rheumatologic device and drug studies patient recruitment, care and follow up, preparation of IRB submissions, study initiation, maintenance of protocol deviations and protocol integrity, adverse event reporting, FDA audits, drug and device accountability, source documentation, data collection and entry, CRF maintenance and creation, study source creation, database development and maintenance, consent writing, compliance with IRB, FDA and GCP-ICH guidelines and regulations, development and maintenance of budget and billing, research staff meetings, conduction of in-services, site staff training and delegation of duties, problem solving, continuous communication with investigators, sponsors, monitors and patients, query generation and resolution, sitting on a DSMB, abstract writing and submission, protocol conception, development and execution.
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