Sr. Regulatory Coordinator

Children's Hospital Los Angeles (CHLA); Los Angeles (CA); Remote; USD 70,000 - 90,000; Full time

Job summary

Children's Hospital Los Angeles is seeking a Senior Regulatory Coordinator to manage regulatory and compliance activities for clinical research. The role involves preparing and submitting protocols to IRBs, external boards, and committees, maintaining study documentation, and generating regulatory reports.

Ideal candidates have 3+ years in healthcare or clinical research, a Bachelor’s degree, and knowledge of FDA regulations, ICH/GCP guidelines, and HIPAA constraints.

Qualifications

• Minimum 3 years of experience in healthcare or clinical research.
• Regulatory experience including submitting documents to regulatory bodies.

Responsibilities

• Prepare and submit protocols and supporting documents to IRBs and regulatory bodies.
• Maintain research files and documentation; generate reports and respond to sponsor questions.
• Ensure GCP compliance and patient confidentiality per HIPAA and applicable law.

Skills

Regulatory coordination

IRB submissions

GCP knowledge

HIPAA compliance

Electronic data submission

Education

Bachelor's degree

Tools

Electronic data submission software

Job description

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

• 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.