Regulatory Coordinator
October 12
Description
• Regulatory Coordinators ensure all clinical trials adhere to regulatory requirements. • Manage multiple sites and studies simultaneously with attention to detail. • Responsible for regulatory updates and documentation like IRB submissions. • Provide support and training to clinical research staff and contribute to compliance SOPs. • Participate in audits and review regulatory documents for accuracy. • Stay updated on regulatory trends to assess their impact on trials. • Ensure trial documentation is thorough and inspection-ready. • Foster communication and collaboration among regulatory authorities and sponsors.
Requirements
• Bachelor's Degree or equivalent 4 years of work experience • 3+ years of formal work experience in clinical research, including • 2+ years of experience in regulatory, specifically in clinical trials • 3+ years of experience with Good Clinical Practice (GCP), FDA, and ICH guidelines • 3+ years of experience working with electronic document management systems
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