Regulatory Compliance Specialist

1 week ago


Durham, North Carolina, United States Duke Health Full time

Regulatory Compliance Specialist

About Duke Health

Duke Health is a world-renowned healthcare system dedicated to providing exceptional patient care, advancing medical research, and educating the next generation of healthcare professionals.

Job Summary

We are seeking a highly skilled Regulatory Compliance Specialist to join our team. As a Regulatory Compliance Specialist, you will play a critical role in ensuring compliance with regulatory requirements and guidelines related to clinical research and healthcare operations.

Key Responsibilities

  • Regulatory Compliance
    • Develop and implement regulatory compliance strategies to ensure adherence to FDA regulations, institutional policies, and study protocols.
    • Conduct regular audits and assessments to identify areas for improvement and implement corrective actions.
  • Study Coordination
    • Coordinate and manage clinical trials and research studies, ensuring compliance with regulatory requirements and study protocols.
    • Collaborate with investigators, research staff, and other stakeholders to ensure timely and accurate completion of study-related tasks.
  • Documentation and Reporting
    • Prepare and submit regulatory documents, including FDA submissions and IRB applications.
    • Develop and maintain accurate and comprehensive records of regulatory compliance activities.

Requirements

  • Education
    • Associate's degree or equivalent experience.
  • Experience
    • Minimum of two years of experience in regulatory compliance, clinical research, or a related field.

What We Offer

Duke Health offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are an equal opportunity employer committed to diversity and inclusion.



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