Regulatory Coordinator

4 weeks ago


Durham, North Carolina, United States Duke Health Full time

Job Summary

Duke Health is seeking a highly skilled Regulatory Coordinator to join our team. As a key member of our clinical research team, you will be responsible for ensuring compliance with regulatory requirements and institutional policies. Your expertise will be essential in maintaining accurate and up-to-date documentation, preparing regulatory submissions, and addressing FDA review and hold issues.

Key Responsibilities

  • Develop and submit documentation and information for IRB review
  • Communicate with IRB staff and reviewers, and handle issues appropriately
  • Prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies
  • Enter and collect basic data for research studies
  • Score scripted or validated tests and measures
  • Recognize and report security of physical and electronic data vulnerabilities

Requirements

  • Completion of an Associate's degree
  • Minimum of two years of research and/or regulatory experience
  • Strong understanding of regulatory and institutional policies and processes
  • Excellent communication and interpersonal skills

About Duke Health

Duke Health is a world-class academic medical center dedicated to providing exceptional patient care, advancing medical knowledge, and training the next generation of healthcare professionals. Our team is committed to creating a culture of inclusivity, diversity, and respect, where everyone feels valued and supported.



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