Regulatory Coordinator
4 weeks ago
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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