Research Quality and Assurance Specialist

About the role

This position requires expert judgment and deep knowledge of clinical research regulations and quality systems. The role involves analyzing complex documentation, performing detailed data verification, and managing CAPA follow-up with minimal supervision.

Responsibilities

• Provide guidance to influence research practices
• Collaborate across teams
• Develop training materials
• Ensure regulatory compliance, research integrity, and organizational risk mitigation by applying expertise in ICH GCP, FDA CFR, HIPAA, IRB processes, and SOPs

Qualifications

• Minimum of three years in clinical research with monitoring, auditing, or QA/QC experience
• Oncology or Hematology research experience is preferred
• Bachelor's degree in science, healthcare, or related field; RN preferred

Skills

• Familiarity with regulatory systems like Complion, Epic, REDCap, and clinical trial processes is advantageous
• Certifications such as SOCRA or ACRP are preferred