Research Quality and Assurance Specialist

Role Overview

This position demands expert knowledge in clinical research regulations and quality assurance systems. Key responsibilities involve meticulous review of documentation, validation of clinical data, and management of Corrective and Preventive Actions (CAPA) with minimal oversight.

Impact and Collaboration

The specialist actively shapes research procedures by providing expert advice, collaborating across teams, and creating training materials. Their work significantly supports regulatory compliance, research integrity, and minimizes risks within the organization.

Qualifications

• At least three years of professional experience in clinical research roles such as monitoring, auditing, or quality assurance/control.
• Preference is given to candidates experienced in oncology or hematology clinical studies.
• Bachelor’s degree in science, healthcare, or related discipline is required; a Registered Nurse (RN) qualification is favored.
• Comprehensive understanding of regulatory frameworks including ICH GCP, FDA CFR, HIPAA, IRB protocols, and SOP implementation.

Technical & Certification Requirements

• Familiarity with systems such as Complion, Epic, REDCap, and NCI CTSU is important.
• Certifications like SOCRA or ACRP provide additional advantage.

Role Importance

This role is critical to uphold compliance and quality standards, ensuring the integrity and reliability of clinical research activities.