Pediatric Regulatory & Compliance Coordinator

Jobtailor; Madison (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

Jobtailor in Madison, WI seeks a Regulatory Compliance Specialist to support pediatric research studies. You will review regulatory documents, ensure adherence to frameworks, and guide study teams on compliance. The role involves preparing consent materials and communicating with protocol sponsors.

Ideal candidates will have strong communication, organizational, and problem-solving skills, plus experience with IRB submissions and regulatory systems like REDCap or OnCore.

Qualifications

• Bachelor's degree preferred in a relevant field.
• Experience with Institutional Review Board submissions preferred.
• Effective oral and written communication is required.
• Ability to manage multiple projects with strong attention to detail.
• Experience with IRB-related systems (REDCap/ARROW/OnCore) is advantageous.

Responsibilities

• Provide regulatory support for research studies in the Department of Pediatrics.
• Review documents, applications, agreements, and reports for compliance.
• Ensure adherence to regulatory frameworks, laws, and standards.
• Apply regulatory skills across study types and identify escalation needs.
• Perform quality checks and potentially train staff.
• Develop new team and unit processes, procedures, tools, and training.
• Guide research teams on policy and regulatory compliance.
• Communicate with protocol sponsors about regulatory activities.
• Maintain complete regulatory files and records.
• Serve as regulatory contact for human-subjects research.
• Develop clear informed consent documents.
• Prepare and submit protocol-specific materials to IRB and scientific review committees

Skills

Communication

Problem-solving

Attention to detail

Organizational skills

Prioritization

Service-oriented

Independent thinking

Analytical skills

Education

Bachelor's degree preferred

Tools

REDCap

ARROW

OnCore

HealthLink

Microsoft Office Suite

Adobe Acrobat

Google Drive

Box

Job description

Jobtailor in Madison, WI seeks a Regulatory Compliance Specialist to support pediatric research studies. You will review regulatory documents, ensure adherence to frameworks, and guide study teams on compliance. The role involves preparing consent materials and communicating with protocol sponsors.

Ideal candidates will have strong communication, organizational, and problem-solving skills, plus experience with IRB submissions and regulatory systems like REDCap or OnCore.