Neuroscience Regulatory Coordinator I – Grow in Research

Cedars-Sinai; Los Angeles (CA); In loco; USD 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

Cedars-Sinai Medical Center in Los Angeles seeks a Regulatory Coordinator I to support the Neurology and Neurosurgery departments. You will prepare and submit protocols to regulatory bodies, maintain filings, and ensure compliance with GCP, HIPAA, FDA and IRB requirements.

You will collaborate with the clinical trial team, respond to IRB/IACUC questions, generate reports, and keep study documentation up to date, while attending team meetings and training sessions.

Competenze

• Bachelor's degree required.
• Minimum 1 year of directly related experience required.
• Specialty research certification preferred.

Mansioni

• Submits continuations and amendments as necessary to maintain regulatory compliance.
• Responds to all IRB or IACUC questions related to regulatory aspects of the study.
• Completes forms and generates reports to follow regulatory requirements and policies.
• Works closely with the clinical trial coordinator, research staff, and investigators to keep regulatory documents up-to-date.
• Attends research team meetings and updates staff and investigators on submission status.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains patient confidentiality per HIPAA and applicable laws.
• Participates in required training and education programs.

Conoscenze

GCP knowledge

HIPAA compliance

Formazione

Bachelor's degree

Descrizione del lavoro

Cedars-Sinai Medical Center in Los Angeles seeks a Regulatory Coordinator I to support the Neurology and Neurosurgery departments. You will prepare and submit protocols to regulatory bodies, maintain filings, and ensure compliance with GCP, HIPAA, FDA and IRB requirements.

You will collaborate with the clinical trial team, respond to IRB/IACUC questions, generate reports, and keep study documentation up to date, while attending team meetings and training sessions.