Sr. Regulatory Coordinator

• This is a fully remote position; however, candidates must reside in California*

Schedule: Full-Time, Exempt. Standard Monday-Friday business hours.

Purpose Statement/Position Summary: The Regulatory Coordinator, Sr. 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 Sr also submits continuation reviews, amendments, responds to questions from sponsors, institutional departments, or regulatory bodies, generates reports, and maintains research files and documentation required for the study or clinical trial.

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:

• 3 years of experience in healthcare / clinical research or a related field (e.g., healthcare, laboratory, or data management).
• Prior regulatory experience including submitting documents to regulatory bodies and agencies.

Preferred:

• Proficient knowledge of Food and Drug Administration (FDA) regulations and International Conference on Harmonization (ICH) and GCP guidelines governing the protection of human research subjects.
• Experience using electronic data submission software.

Education/Licensure/Certification Required:

• Bachelor’s Degree in a related field; or an equivalent combination of education and experience.

Preferred:

• RAPS, ACRP/SoCRA (or equivalent) certification.