Rafael Skorka M.D. Facc Faha
Manager Medical Safety Officer @Edwards Lifesciences
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WORK HISTORY
Manager Medical Safety Officer @Edwards Lifesciences
Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient reported outcomes and enhance lives- Conducting medical assessment of adverse events and device deficiencies reported through clinical trials and product safety- Responsible for the medical safety and clinical development of cardiological trials, providing clinical study reports outcomes and analyzing the data, according to the frequency established in the protocols- Collaborate according to regulatory requirement with medical affairs, for developing the CEC, DSMB/DMC charters, and scope of works- Provide the medical input along the cross-functional teams (Medical Writing, Biostatistics, Medical affairs) for global development of medical trials-Managing the safety sections of study protocols, regulatory submissions, and clinical/regulatory reports, including clinical risk/benefit analysis as required- Coordinate training and education of other personnel. Preparing and teaching cardiological lectures to different areas of the company (among them: Safety team, Monitoring team, Clinical affairs, Regulatory affairs)- Provides assistance with project budget, billing and reconciliation.
EDUCATION
ICON
CRO, Clinical Research Organization
Universidad Favaloro
Internal Medicine Residency Program
Universidad Favaloro
Cardiac Medicine Certification (CMC), Cardiovascular Disease Residency Program
Universidad Favaloro
Certified Cardiac Rehabilitation Professional (CCRP), Post-Graduate Degree Subspecialty in Cardiac and Pulmonary Rehabilitation at Favaloro Foundation
Universidad Maimónides
Doctor of Medicine - MD, Medicine
Ministry of Education, Culture and Sports Spain
Doctor of Medicine - MD, Medical License in Spain
Escuela Tecnica ORT
High School Technician with orientation in Chemistry
Harvard University
Health Care Quality Improvement: From Design to Implementation, Health/Health Care Administration/Management
Cedars Sinai Medical Group
Certified Clinical Research, Clinical Research Coordinator
ABOUT RAFAEL SKORKA M.D. FACC FAHA
As a Clinical Research Medical Director in Cardiology, I have spent more than 14 years immersed in the medical field. My passion lies in improving patient outcomes and enhancing lives through cutting-edge clinical research and cardiology practice.My expertise extends to medical safety where I ensure the implementation of stringent protocols and guidelines across all clinical trials. As part of my role at Cedars-Sinai, an organization celebrated for its pioneering advancements in healthcare, I am committed to setting new standards for patient care quality and innovation.Further strengthening my credentials is my experience in Cardiovascular and Cardio-Metabolic diseases, as well as Development of research programs, Clinical Data Management, Regulatory Affairs and Leadership. I\'ve honed my creativity and innovation skills to devise successful strategies for managing complex clinical trials while ensuring medical safety. I am eager to bring this wealth of knowledge into new challenges where I can continue making strides in medical field research.
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