Senior Research Compliance Auditor – FDA & External Audits

Miami Children’s Hospital; Miami (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Miami Children’s Hospital is seeking a Sr. Research Compliance Specialist to ensure adherence to regulatory requirements and institutional policies governing clinical research. The role leads audits, serves as liaison for FDA inspections, and partners with study teams to address findings.

The specialist provides expert guidance, mentors staff, and drives quality improvement across the research portfolio, maintaining audit readiness and compliance with sponsor requirements.

Qualifications

• Bachelor's Degree in Sciences or Education or equivalent.
• 7–10 years clinical research and/or monitoring or auditing experience.
• 3–5 years direct experience in regulatory auditing/monitoring, including hands-on FDA audits/sponsor inspections.

Responsibilities

• Plans, conducts, and documents routine, for-cause, and preparatory audits across clinical research studies.
• Leads preparation for FDA audits and other external inspections; addresses non-compliance concerns.
• Develops and tracks CAPAs; monitors effectiveness of corrective actions.
• Provides compliance guidance and mentorship to investigators and staff; maintains audit readiness.

Skills

FDA audits

CTMS / e-Reg system

Mentoring

Regulatory compliance

Confidentiality

Education

Bachelor's Degree in Sciences or Education

Tools

CTMS / e-Reg system

Job description

Miami Children’s Hospital is seeking a Sr. Research Compliance Specialist to ensure adherence to regulatory requirements and institutional policies governing clinical research. The role leads audits, serves as liaison for FDA inspections, and partners with study teams to address findings.

The specialist provides expert guidance, mentors staff, and drives quality improvement across the research portfolio, maintaining audit readiness and compliance with sponsor requirements.