Pediatric Clinical Research Regulatory Coordinator

Ann & Robert H. Lurie Children's Hospital of Chicago; Chicago (IL); On-site; USD 66,000 - 107,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

403(b) with a 5% employer match

Paid Time Off (PTO) & Holidays

Job summary

Ann & Robert H. Lurie Children’s Hospital of Chicago seeks a Regulatory Coordinator to oversee regulatory review and approval for clinical research studies involving human subjects.

You will ensure regulatory compliance across IRB submissions, amendments, safety reports, and study reporting, collaborating with PIs and study staff throughout the lifecycle. You will coordinate communications with affiliate institutions, sponsors, and oversight bodies, track new regulations, prepare consent

Qualifications

• Bachelor's degree or the equivalent with three years in regulatory/research.
• Knowledge of federal, state, and local regulations and ethical principles in human subjects research (ICH-GCP, OHRP, FDA).
• Strong customer service, project management, and process improvement skills.

Responsibilities

• Determines and interprets applicable rules and regulations for complex clinical research studies involving human subjects.
• Guides and coordinates all regulatory submissions, documentation, and reporting processes (new studies, renewals, amendments, adverse events, safety reports, close-out).
• Acts as liaison between affiliate institutions, sponsors, coordinators, investigators and oversight agencies.
• Tracks and applies new rules and regulations and ensures submission of appropriate documents to IRB and other groups.
• Drafts protocols and informed consent; ensures accuracy of IRB approval letters.
• Provides guidance and training to research staff on regulatory requirements.
• Alerts staff to regulatory changes and applies them to studies.
• Creates reports and analyses regarding compliance requirements and process improvements.
• Provides guidance on institutional policies and funding regulations; compliance program components include research safety and COI reporting.
• Other job functions as assigned.

Skills

Regulatory compliance

IRB coordination

Clinical research

Documentation

Communication

Project management

Attention to detail

Education

Bachelor's Degree in Risk Management

Tools

EPIC

Excel

Word

Outlook

Access

PowerPoint

Job description

Ann & Robert H. Lurie Children’s Hospital of Chicago seeks a Regulatory Coordinator to oversee regulatory review and approval for clinical research studies involving human subjects.

You will ensure regulatory compliance across IRB submissions, amendments, safety reports, and study reporting, collaborating with PIs and study staff throughout the lifecycle. You will coordinate communications with affiliate institutions, sponsors, and oversight bodies, track new regulations, prepare consent