Regulatory Coordinator II (Remote)

About the role

The Regulatory Coordinator II plays a crucial role in ensuring that all research studies and clinical trials comply with regulatory requirements and institutional policies.

Responsibilities

• Prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS (if needed), Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in Pre/Post-award process.
• Sets up and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
• Attends research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.

Qualifications

• Bachelor's Degree.
• Minimum of 3 years of directly related experience in clinical research regulatory affairs, including preparing and submitting regulatory documents, managing IRB and/or IACUC submissions, maintaining study regulatory files, and ensuring compliance with FDA, GCP, HIPAA, and institutional requirements.