Research Quality and Assurance Specialist

About the Role

This position requires expert judgment in clinical research regulations and quality systems, with responsibilities including analyzing documentation, performing data verification, and managing CAPA follow-up with minimal supervision. The role involves influencing organizational practices and ensuring compliance to safeguard research integrity and organizational risk management.

Responsibilities

• Provide guidance to influence research practices and develop training materials.
• Ensure regulatory compliance and research integrity by adhering to ICH GCP, FDA CFR, HIPAA, IRB processes, and SOPs.
• Collaborate across departments to maintain regulatory readiness and quality standards.
• Perform detailed reviews, data verification, and support quality assurance activities.

Requirements

• Minimum of 3 years of clinical research experience in monitoring, auditing, or QA/QC, preferably in Oncology or Hematology.
• Bachelor’s degree in science, healthcare, or related field; RN degree preferred.
• Knowledge of regulatory systems like Complion, Epic, REDCap, and familiarity with NCI CTSU systems preferred.
• Certifications such as SOCRA (CCRP) or ACRP are advantageous.