Regulatory Coordinator I - Neurosciences

Cedars-Sinai; Los Angeles (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

• 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.

Skills

GCP knowledge

HIPAA compliance

Education

Bachelor's degree

Job description

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.

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.