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Company

Cedars-Sinai · 8 hours ago

Regulatory Coordinator III, Remote

Beverly Hills, CA

Full-time

Remote

Mid, Senior Level

$37.66/hr - $64.02/hr

5+ years exp

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Responsibilities

Provides supervision of other regulatory staff.

Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC.

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.

Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.

Meets with monitors from pharmaceutical companies and represents the medical center during these meetings.

Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.

Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.

May participate in internal auditing of regulatory documents.

May supervise Regulatory Coordinator I/II and/or provide training and education of other personnel.

May participate in centralized activities of the department or institution.

May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs.

May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.

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.

Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Participates in required training and education programs.

Qualification

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Regulatory ExperienceLeadership ExperienceSpecialty research certificationClinical Practice (GCP)HIPAA regulationsClinical trial coordinationResearch documentationInternal auditing

Required

BA/BS Degree required

Five (5) years minimum of directly related experience.

Leadership Experience: Minimum of 3 years leading a team, preferably with more than 5 staff.

Regulatory Experience: Minimum of 5 years managing 30+ studies, ideally within a Cancer Center setting.

Preferred

Specialty research certification preferred.

Company

Cedars-Sinai

Glassdoor

4.0

Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service.

Founded in 1902

Los Angeles, California, USA

10001+ employees