Senior Research Compliance Lead: FDA Audits & Quality

Nicklaus Children's Health System; Sunset Corners (FL); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Nicklaushealth is seeking a Senior Research Compliance Specialist to ensure adherence to applicable regulatory requirements and institutional policies in clinical research, with emphasis on industry-sponsored studies. The role leads internal audits and serves as the primary liaison for FDA inspections.

You will mentor junior staff, develop CAPA plans, and translate new regulations into SOPs, supporting audit readiness and continuous quality improvement across the research portfolio.

Qualifications

• Bachelor's degree required or 6 years additional clinical research experience.
• 7–10 years clinical research/monitoring/auditing, including external trials.
• 3–5 years direct regulatory/compliance auditing experience, including FDA/sponsor audits.
• Certifications: CHRC, CCRP, ACRP-CP, or SOCRA.

Responsabilités

• Serve as senior SME for laws, regulations, and best practices governing industry-sponsored and externally sponsored research.
• Plan, conduct, and document audits across clinical research studies, focusing on industry-sponsored trials.
• Evaluate study conduct for protocol, informed consent, sponsor requirements, regulatory submissions, and policies.
• Review informed consent forms, source documents, eCRFs, and regulatory binders for accuracy and data integrity.
• Assess credentialing, training, and delegation to ensure compliance.
• Identify audit findings, trends, and systemic risks; escalate significant findings.
• Prepare audit reports with corrective and preventive actions (CAPAs).
• Lead FDA audits and external inspections; liaise with study teams to address concerns.
• Monitor regulatory changes and translate them into policies and SOPs.
• Provide compliance education to investigators and staff; promote audit readiness.
• Mentor junior staff on audit methodology and requirements.
• Collaborate with leadership to support quality improvement initiatives.
• Maintain audit records, metrics, and compliance data for reporting.
• Communicate findings professionally while maintaining confidentiality.

Formation

Bachelor's Degree in Sciences or Education (OR) 6 years of additional clinical research experience.

7-10 years Clinical Research and/or monitoring or auditing experience, including substantial experience with industry-sponsored and other externally sponsored clinical trials.

3-5 years Direct experience in regulatory or compliance auditing/monitoring, including hands-on experience supporting or leading FDA audits, sponsor audits, or other external regulatory inspections.

CHRC, CCRP, ACRP-CP, or SOCRA Certification.

Outils

CTMS / e-Reg system

Description du poste

Nicklaushealth is seeking a Senior Research Compliance Specialist to ensure adherence to applicable regulatory requirements and institutional policies in clinical research, with emphasis on industry-sponsored studies. The role leads internal audits and serves as the primary liaison for FDA inspections.

You will mentor junior staff, develop CAPA plans, and translate new regulations into SOPs, supporting audit readiness and continuous quality improvement across the research portfolio.