Regulatory Compliance Specialist

2 weeks ago


Birmingham, Alabama, United States Medix™ Full time
Job Summary

We are seeking a highly skilled Regulatory Coordinator to join our team at Medix™. As a key member of our clinical research operations, you will be responsible for ensuring compliance with regulatory requirements and guidelines.

Key Responsibilities
  • Prepare and submit research documentation, including IRB submissions, educational materials, reports, and study forms.
  • Prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
  • Lead the implementation of study-specific regulatory processes of a moderate to complex nature.
  • Conduct internal quality assurance audits of regulatory files and programs.
  • Design and implement quality initiatives to ensure effective and efficient clinical processes.
Qualifications

Bachelor's degree in a related field and five (5) years of related experience required. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.

We are looking for a detail-oriented and organized individual with excellent communication skills and the ability to work independently as well as within a team. If you are a motivated and self-directed professional with a passion for regulatory compliance, we encourage you to apply for this exciting opportunity.



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