Regulatory Coordinator Lead

Job Description


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.

Pay Scale Information


$71,781.00-$123,053.00

CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to, education and experience within the job or the industry. The pay scale listed for this position is generally for candidates who meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates who exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs.

About Us


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.

CHLA is an Equal Opportunity Employer


At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance.


Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process.


Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA.