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Children's Hospital Los Angeles (CHLA) · 2 weeks ago

Clinical Research Regulatory Affairs Manager / Hybrid

Los Angeles, CA

Full-time

Hybrid

Senior Level

$104K/yr - $179K/yr

6+ years exp

Children's Hospital Los Angeles (CHLA) is ranked among the top 10 pediatric hospitals in the nation, providing exceptional care for children. The Manager, Clinical Research Regulatory Affairs is responsible for overseeing the Regulatory Affairs department and ensuring compliance with various regulations while supporting clinical research studies.

Health Care

Responsibilities

Oversight and governance of Regulatory Affairs department

Day-to-day support of the clinical research studies

Advocates for the advancement of critical strategic objectives

Promote effective, efficient, and compliant management of clinical studies

Ensures compliance with local, state, and federal laws

Ensures compliance with accreditation, professional and regulatory agency standards

Ensures compliance with licensure requirements

Qualification

Clinical research experienceRegulatory experienceFDA regulations knowledgeICH guidelines knowledgeClinical Practice (GCP)Bachelor’s degreeSupervisory experienceMaster’s degreeACRP/SOCRA certification

Required

6 years of experience in clinical research (e.g., research, clinical, interaction with study population, program coordination)

2 years prior regulatory experience

Advanced knowledge of Food and Drug Administration (FDA) regulations and International Conference of Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines governing the protection of human research subjects

Bachelor's degree in a related field or an equivalent combination of education and experience