Ornat Katzir, MSc., MHA, has over 15 years of experience in clinical research:

• CRA and GCP manager in a US international pharmaceutical company
• Sr.CRA, Principal CRA, Team manger and Local Associate Clinical Operations manager of a large US CRO
• Quality Management Systems Associate of a large US international CRO
• Independent Clinical Research Consultant, GCP auditor and trainer

He has hands on experience in various aspects of clinical research:

• Monitoring and management of all stages of clinical research
• Development and review and assessment of clinical research documents and tools (Protocols, Informed Consent Forms, Case Report Forms, Questionnaires etc.) for compliance with applicable standards and regulations
• Development, review and assessment of internal systems/processes, standard operating procedures and working practice documents for compliance with applicable standards and regulations
• Systems and process audits and development of methodology and tools for these audits/reviews
• Development and quality check of documents summarizing the requirements for clinical trials in specific regions/countries
• Conduct of sponsors, CROs, sites and vendors GCP Audits
• Training clinical research personnel (sponsor/CRO and research sites teams)