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Regulatory Coordinator
Location/Org Data : Introduction
Join a team that's shaping the future of pediatric care. Children’s Hospital Los Angeles is consistently ranked among the top 10 children's hospitals in the nation, delivering world-class care through more than 350 specialized programs and services. Here, world-class experts in medicine, research, and education work together to deliver family-centered care to more than 155,000 patients each year. At CHLA, your work will help build brighter tomorrows for the children and families we serve.Overview
This is 100% remote position. CHLA requires a primary residence in California prior to start date.Schedule: Day Shift
Purpose Statement/Position Summary: The Regulatory Coordinator plays an integral role in the regulatory and compliance process of clinical research conducted at CHLA. This position involves preparing and submitting protocols and supporting documents to regulatory bodies and agencies, such as the CHLA Institutional Review Board (IRB), External IRB, Clinical Radiation Safety Committee, Institutional Biosafety Committee (IBC), and any other research committees involved in regulatory review and approval processes.The Regulatory
Coordinator responds to questions from sponsors, institutional departments, or regulatory bodies, generates reports, and maintains research files and documentation involving study regulatory requirements.Maintains research practices using Good Clinical Practice (GCP) guidelines and strict patient confidentiality according to Health Insurance Portability and Accountability Act (HIPAA) regulations and applicable law.
Minimum Qualifications/Work Experience:
Required:
- 1 year of experience in healthcare / clinical research or a related field (e.g., healthcare, laboratory, or data management).
- Experience in clinical research compliance and/or regulatory research.
- Prior experience in submitting documents to regulatory bodies and agencies.
- Knowledge of Food and Drug Administration (FDA) regulations and International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines governing the protection of human research subjects.
- Experience using electronic data submission software.
Required:
- Bachelor’s Degree in a related field; or an equivalent combination of education and experience.
- RAPs, ACRP/SoCRA (or equivalent) certification.
Since 1932, CHLA has been affiliated with the Keck School of Medicine of the University of Southern California. Through this partnership and our own enduring mission, we remain committed to creating hope and building healthier futures.
