Research Quality and Assurance Specialist

About the role

We are seeking a skilled professional to lead clinical research quality and compliance efforts.

Responsibilities

• Provide expert guidance on regulatory requirements such as ICH GCP, FDA CFR, HIPAA, IRB processes, and SOP adherence
• Analyze complex documentation
• Perform detailed data verification
• Manage CAPA follow-up
• Develop training and educational materials

Requirements

• Minimum of three years of clinical research experience in monitoring, auditing, or QA/QC
• Oncology or hematology research experience preferred
• Bachelor’s degree in science, healthcare, or related fields (required)
• RN degree (a plus)

Qualifications

• Familiarity with systems like Complion, Epic, REDCap, and NCI CTSU (advantageous)
• Certification such as SOCRA (CCRP) or ACRP (preferred)

Skills

• Strong judgment and decision-making
• Knowledge of human anatomy, physiology, and medical terminology
• Ability to collaborate across functions to influence research practices