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Regulatory Compliance Specialist

4 weeks ago

Atlanta, Georgia, United States Children's Healthcare of Atlanta Full time
Job Summary

We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Children's Healthcare of Atlanta. As a key member of our research operations team, you will play a critical role in ensuring the compliance of our clinical research studies with federal regulations and institutional policies.

Key Responsibilities
  • Develop and submit regulatory documents required for FDA submissions, Institutional Review Board submissions, and other required documents for the initiation of clinical research studies.
  • Draft, review, edit, and finalize documents by organizing, analyzing, and interpreting scientific and statistical data.
  • Serve in a quality regulatory compliance role to support Children's IRB and other internal research departments to ensure study conduct adheres to institutional policies, as well as state and federal regulations.
Requirements
  • Three years of experience in clinical research in a medical/behavioral setting, with knowledge about the conduct of clinical trials, research principles, and methodologies/study design.
  • One year of experience developing, submitting, and executing clinical research projects.
  • Master's degree in a scientific or health-related field.
Preferred Qualifications
  • Bachelor's degree in a scientific or health-related field or a bachelor's degree in a non-scientific or health-related field with relevant experience.
  • Collaborative Institutional Training Initiative (CITI) certification within 30 days of employment.
What We Offer

Children's Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability, or any other characteristic covered by applicable law.