Regulatory Coordinator I - Neurosciences - Los Angeles, CA

VetJobs; Los Angeles (CA); On-site; USD 40,000 - 68,000; Full time

Job summary

VetJobs seeks a Regulatory Coordinator I to support the Neurology and Neurosurgery departments at Cedars-Sinai Medical Center. The role submits protocols to PPC, PRMC, IBCS, and IRB, maintains regulatory files, and ensures regulatory compliance across FDA and local IRBs.

Responsibilities include preparing continuations/amendments, responding to IRB/IACUC inquiries, and collaborating with staff to keep all submissions current, with emphasis on GCP and patient privacy under HIPAA.

Qualifications

• One year minimum of directly related experience is required.
• Specialty research certification is preferred.

Responsibilities

• Submits continuations and amendments to maintain regulatory compliance.
• Responds to IRB/IACUC questions related to regulatory aspects.
• Completes forms and generates reports to follow regulatory requirements.
• Coordinates with trial staff to keep regulatory documents up-to-date.
• Attends research team meetings and updates staff and investigators.
• Maintains Good Clinical Practice (GCP) guidelines in daily workflows.
• Ensures HIPAA confidentiality and compliance with applicable laws.
• Participates in required training and education programs.

Skills

Regulatory knowledge

GCP knowledge

HIPAA compliance

Communication skills

Education

Bachelor's degree

Specialty research certification

Job description

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers.

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.

Minimum Education Required

Bachelors

Education, Experience, And Skills:

Bachelor's degree, required.

One (1) year minimum of directly related experience is required.

Specialty research certification, preferred.

Minimum Salary

28.86

Maximum Salary

49.06

Certificates/Security Clearances/Other

City* Los Angeles

State* California

Job_Category Coordinator

Job Code Health-Services health-services

Affiliate Sponsor Cedars-Sinai