Join a team that's shaping the future of pediatric care. Children’s Hospital Los Angeles is consistently ranked among the top 10 children's hospitals in the nation, delivering world-class care through more than 350 specialized programs and services. Here, world-class experts in medicine, research, and education work together to deliver family-centered care to more than 155,000 patients each year. At CHLA, your work will help build brighter tomorrows for the children and families we serve.
Overview:Purpose Statement/Position Summary:
The Lead Regulatory Coordinator guides, supports and mentors an operational team. Serves as primary resource for the work day. Determines specific work assignments for the shift. Acts as the “lead individual” on weekends or other periods of reduced staffing when no Supervisor is on-site. Understands the allocation of staff and operational resources, collaborating decisions with direct Supervisor and Manager to schedule staff appropriately, suggesting additional staffing and operational resources as needed.
Submits protocols and supporting documents to regulatory bodies and agencies, such as the CHLA Institutional Review Board (IRB), External / Commercial IRBs, Clinical Radiation Safety Committee, Institutional Biosafety Committee (IBC), and any other research committees involved in regulatory review and approval processes. Submits continuation reviews, amendments, responds to questions from sponsors, institutional departments, or regulatory bodies, generates reports, and maintains research files and documentation involving the regulatory requirements for the study or clinical trial. This position also plans and coordinates strategies for improving efficiency, action plans to improve quality, and training regulatory personnel.
Maintains research practices using Good Clinical Practice (GCP) guidelines and strict patient confidentiality according to Health Insurance Portability and Accountability Act (HIPAA) regulations and applicable law
Minimum Qualifications/Work Experience:
Required:
• 4 years of experience in clinical research or a related field (e.g., healthcare, laboratory, or data management).
• Prior regulatory experience.
• Proficient knowledge of Food and Drug Administration (FDA) regulations and International Conference Harmonisation (ICH) and GCP guidelines governing the protection of human research subjects.
• Experience using electronic data submission software.
• Excellent verbal / written communication and interpersonal skills.
• Strong organizational and time management skills, with the ability to handle multiple tasks and meet deadlines.
• Experience initiating and evaluating operational initiatives to improve quality, throughput, and care. Ability to lead others and apply organizational skills. Ability to communicate effectively and tactfully verbally and in writing.
• Preferred: Previous lead experience. Thorough knowledge of the principles pertaining to the area of responsibility.
Education/Licensure/Certification:
• Required: Bachelor’s or Associates degree in a related field; or equivalent combination of education and experience.
• Preferred: CIP, SoCRA or ACRP certification.
CHLA is a leader in pediatric and adolescent health, in our community, across the nation, and around the world . As a premier Magnet®-recognized teaching hospital, CHLA offers an environment rooted in learning, collaboration, and compassionate care. . We are home to groundbreaking research, clinical innovation, and a culture that supports personal and professional growth.
Since 1932, CHLA has been affiliated with the Keck School of Medicine of the University of Southern California. Through this partnership and our own enduring mission, we remain committed to creating hope and building healthier futures.