Head of Clinical Research Quality & Compliance

Memorial Healthcare System; Florida; On-site; USD 140,000 - 210,000; Full time

Job summary

Memorial Healthcare System seeks a Clinical Research Quality Assurance Director to provide strategic and operational oversight of the institution’s QA program in Hollywood, Florida. You will champion audits, CAPA, and continuous improvement to ensure GCP and regulatory compliance across research operations.

Leadershi p experience in academic medical centers or health systems, with deep knowledge of FDA, OHRP, ICH-GCP, and HIPAA requirements, is essential to ensure audit readiness and participant

Qualifications

• Bachelor’s degree in Healthcare, Nursing, Science, Public Health or related field.
• 8+ years of progressive core experience in clinical research, human research protections, research compliance, quality assurance, auditing, or related research administration functions.

Responsibilities

• Serves as a key institutional resource during audits, inspections, and accreditation activities, ensuring timely follow-up, risk mitigation, and resolution of findings.
• Leads and oversees the enterprise clinical research quality assurance and monitoring program, including routine, for-cause, and risk-based reviews.
• Develops, implements, and maintains QA policies, SOPs, CAPA processes, and quality improvement initiatives aligned with regulatory and accreditation standards.
• Monitors evolving federal, state, sponsor, and accreditation requirements such as ICH-GCP E6 updates and ensures timely integration into institutional policies, workflows, and practices.
• Provides training, education and strategic guidance to investigators, research staff, and leadership on GCP, FDA, OHRP, HIPAA, and institutional compliance requirements.

Skills

Leadership

Quality Assurance

Regulatory knowledge

Audit programs

Communication

Education

Bachelor's degree in Healthcare/Life Sciences

Master's degree preferred

Job description

Memorial Healthcare System seeks a Clinical Research Quality Assurance Director to provide strategic and operational oversight of the institution’s QA program in Hollywood, Florida. You will champion audits, CAPA, and continuous improvement to ensure GCP and regulatory compliance across research operations.

Leadershi p experience in academic medical centers or health systems, with deep knowledge of FDA, OHRP, ICH-GCP, and HIPAA requirements, is essential to ensure audit readiness and participant