Clinical Research QA & Compliance Specialist

Memorial Healthcare; United States; On-site; USD 85,000 - 125,000; Full time

Job summary

Memorial Healthcare System seeks a Research Quality and Assurance Specialist to ensure clinical research complies with federal regulations, policies and ethical standards. You will provide quality oversight, conduct audits, and support inspection readiness across the organization.

You will develop training materials, review ICFs for compliance, manage CAPA follow-up, and partner with investigators, regulatory staff, IRB, and IT to improve data integrity and research quality.

Qualifications

• Bachelor's degree in science, healthcare, or related field.
• Minimum 3 years in clinical research QA/auditing.
• Familiarity with regulatory requirements (ICH GCP, FDA CFR, HIPAA) and IRB processes.

Responsibilities

• Plan and conduct audits of research protocols and non-compliance investigations.
• Perform source data verification and queries to ensure data integrity.
• Generate monitoring reports and communicate results to investigators and leadership.
• Manage CAPA follow-up and corrective actions.
• Develop and deliver training materials for research staff and investigators.
• Review informed consent forms for completeness and regulatory compliance.

Skills

Regulatory compliance

Clinical audits

Quality assurance

CAPA follow-up

Training delivery

Education

Bachelor's degree in science/healthcare

Tools

Complion

Epic

REDCap

Job description

Memorial Healthcare System seeks a Research Quality and Assurance Specialist to ensure clinical research complies with federal regulations, policies and ethical standards. You will provide quality oversight, conduct audits, and support inspection readiness across the organization.

You will develop training materials, review ICFs for compliance, manage CAPA follow-up, and partner with investigators, regulatory staff, IRB, and IT to improve data integrity and research quality.