Neuroscience Research Regulatory Coordinator I

Cedars-Sinai; Los Angeles (CA); Vor Ort; USD 65.000 - 85.000; Vollzeit

Zusammenfassung

Cedars-Sinai Medical Center is seeking a Regulatory Coordinator I to support the Neurology and Neurosurgery departments. The role prepares and submits regulatory documents to bodies such as PPC, PRMC, IBCS, IRBs, and related committees involved in pre- and post‑award activities, ensuring FDA and IRB compliance.

The position collaborates with clinical trial staff to maintain up-to-date regulatory files, respond to IRB/IACUC inquiries, generate reports, and participate in team meetings while

Qualifikationen

• Bachelor's degree, required.
• One (1) year minimum of directly related experience is required.
• Specialty research certification, preferred.

Aufgaben

• Submits continuations and amendments to regulatory bodies to maintain compliance.
• Responds to questions from IRB/IACUC regarding regulatory aspects of the study.
• Completes forms and generates reports to follow regulatory requirements.
• Works with clinical trial staff and investigators to keep regulatory documents up‑to‑date.
• Attends research team meetings and updates on submission status and amendments.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains HIPAA-compliant patient confidentiality.

Kenntnisse

Regulatory coordination

GCP compliance

HIPAA compliance

Attention to detail

Ausbildung

Bachelor's degree

Jobbeschreibung

Job Description

Are you ready to bring your skills to a world-class healthcare organization recognized as one of the top ten in the United States? Come join our team!

About the Role

This position will provide support to the Departments of Neurology and Neurosurgery at Cedars-Sinai Medical Center.

The Regulatory Coordinator I prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in the Pre-Award/Post-award process. This role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Research Department when meeting with sponsors, attending team meetings, and working with other staff to ensure all regulatory documents and requirements are up-to-date. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities:

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

Qualifications

Education, Experience, and Skills:

• Bachelor's degree, required.
• One (1) year minimum of directly related experience is required.
• Specialty research certification, preferred.