Regulatory and Start Up Specialist - Israel
RemoteIsrael
Job Summary
Conduct site activation and regulatory tasks for assigned studies, serving as the Single Point of Contact for investigative sites, the Site Activation Manager, and project teams. Prepare and review site regulatory documents, including Informed Consent Forms and Investigator Packs, ensuring adherence to SOPs, GCP/ICH guidelines, and local regulations. Distribute completed documents, maintain internal databases and tracking tools, and provide local expertise during project planning and timeline reviews. Perform quality control on site-provided documents, monitor progress, and implement contingency plans as needed. This home-based role requires Hebrew fluency and is based in Israel.
Required Qualifications
- Bachelor's Degree in life sciences or a related field
- 3 years' clinical research or other relevant experience
- equivalent combination of education, training and experience
- Hebrew language fluency
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Knowledge of applicable regulatory requirements, including local regulations, SOPs and company's Corporate Standards
- Understanding of regulated clinical trial environment
- knowledge of drug development process
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