Clinical Research QA Coordinator: Compliance & Audits

Accelerated Clinical Trials

Snellville (GA)

On-site

USD 60,000 - 90,000

Full time

10 hours ago
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Job summary

Accelerated Clinical Trials seeks a detail-oriented Clinical Research Quality Assurance Coordinator (Contract) to support regulatory compliance and quality systems across research operations. The role collaborates with the clinical research team to ensure adherence to GCP, FDA, and IRB requirements while maintaining study integrity.

The coordinator will develop QA procedures, conduct internal audits, support study start-up activities, and prepare teams for external inspections.

Qualifications

  • Bachelor’s degree in a scientific, health-related, or research-focused field.
  • Experience in research compliance, quality assurance, clinical research, laboratory research, or a related field (strongly preferred)
  • Knowledgeable in research regulations and standards (e.g., GCP, IRB processes, data integrity principles).
  • Excellent attention to detail, organizational skills, and written communication abilities.

Responsibilities

  • Monitor research activities to ensure compliance with site SOPs, regulatory requirements (e.g., GCP, FDA, IRB), and study-specific protocols.
  • Assist in developing, implementing, and updating quality assurance procedures, templates, and guidance documents.
  • Conduct routine internal audits, data quality checks, and process reviews; document findings and recommend corrective actions.
  • Assist with study start up process by providing relevant regulatory documents.
  • Support research teams in preparing for external audits and regulatory inspections.
  • Provide training and support on QA processes, documentation standards, and compliance expectations.
  • Assist in reviewing protocols, consent forms, and study materials for accuracy and consistency.

Skills

Attention to detail
Organizational skills
Written communication

Education

Bachelor’s degree in a scientific, health-related, or research-focused field

Job description

Accelerated Clinical Trials seeks a detail-oriented Clinical Research Quality Assurance Coordinator (Contract) to support regulatory compliance and quality systems across research operations. The role collaborates with the clinical research team to ensure adherence to GCP, FDA, and IRB requirements while maintaining study integrity.

The coordinator will develop QA procedures, conduct internal audits, support study start-up activities, and prepare teams for external inspections.

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