Clinical Trials Regulatory Specialist

Lurie Children's; Chicago, Northern (IL, KY); Hybrid; USD 66,000 - 107,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

401(k) with employer match

PTO and holidays

Tuition assistance

Employee health program

Job summary

Lurie Children's is seeking a Regulatory Coordinator to oversee the review and approval process for assigned regulatory portfolios supporting clinical research with human subjects. You will ensure compliance with local, state, federal, sponsor, and institutional regulations, guiding investigators and staff through submission, reporting, and study lifecycle activities.

This role partners with the Office of Research Integrity and Compliance and other stakeholders to maintain robust regulatory

Qualifications

• Bachelor's degree or the equivalent and three years of work experience in regulatory/research environment.
• Knowledge of federal, state, local regulations and ethics in human subject research.
• Experience with ICH-GCP, OHRP, FDA regulations and IRB processes.

Responsibilities

• Determines and interprets applicable rules and regulations for complex clinical studies.
• Collaborates with Office of Research Integrity and Compliance and Corporate Compliance to ensure ongoing compliance.
• Guides and coordinates submissions, documentation, and reporting (new studies, renewals, amendments, adverse events).
• Submits documents to the IRB and other oversight groups and addresses questions.
• Acts as liaison between affiliates, sponsors, coordinators, investigators, and oversight bodies.

Skills

Regulatory compliance

IRB submissions

Documentation drafting

Project coordination

Education

Bachelor's Degree: Risk Management (Required)

Tools

EPIC

Job description

Lurie Children's is seeking a Regulatory Coordinator to oversee the review and approval process for assigned regulatory portfolios supporting clinical research with human subjects. You will ensure compliance with local, state, federal, sponsor, and institutional regulations, guiding investigators and staff through submission, reporting, and study lifecycle activities.

This role partners with the Office of Research Integrity and Compliance and other stakeholders to maintain robust regulatory