Remote Senior Regulatory Coordinator, California

Children's Hospital Los Angeles (CHLA); Los Angeles (CA); Remoto; USD 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

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

Mansioni

• 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.

Conoscenze

Regulatory coordination

IRB submissions

GCP knowledge

HIPAA compliance

Electronic data submission

Formazione

Bachelor's degree

Strumenti

Electronic data submission software

Descrizione del lavoro

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.