Clinical Quality Assurance Auditor - Remote (US)

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is a leading community-based oncology research organization dedicated to pioneering advancements in cancer treatment. With over three decades of experience, SCRI has facilitated more than 850 first-in-human clinical trials, contributing significantly to the approval of many new cancer therapies in the past decade. The institute operates a network of 1,300+ physicians across 200+ locations spanning over 20 states across the U.S.

Role Overview

The Clinical Quality Assurance Auditor plays a pivotal role in advancing quality initiatives within SCRI by planning and executing comprehensive audits to ensure compliance with regulatory standards and promoting continuous improvement.

Key Responsibilities

• Plan and perform audits compliant with GxP standards, including internal, vendor, and site evaluations.
• Develop and execute a risk-focused audit plan to prioritize audit activities effectively.
• Conduct interviews with essential personnel to verify process adherence, support inspection readiness, and identify opportunities for process enhancement.
• Document audit findings and improvement suggestions in detailed reports and communicate these to relevant stakeholders.
• Escalate critical quality deficiencies to organizational leadership and other appropriate parties.
• Monitor and review audit responses ensuring timely and adequate corrective actions until audit closure.
• Carry out additional duties as assigned.

Required Qualifications and Experience

• Bachelor’s degree is mandatory.
• Minimum of three years of professional experience within regulated clinical research environments, specifically in Quality Assurance auditing.
• In-depth knowledge of FDA regulations and Good Clinical Practice (GCP) standards.
• Understanding of 21 CFR Part 11 requirements and software validation processes.
• Certification such as SQA Professional, RQA-Certified Quality Auditor, or equivalent is strongly desired.

Additional Information

This is a US-based remote position; relocation assistance and visa sponsorship are not provided. SCRI is committed to diversity and equal opportunity employment, providing a competitive salary package with comprehensive benefits supporting physical, mental, and financial health. Candidates should be aware of fraudulent recruitment activities claiming association with McKesson and exercise caution when engaging with job offers or communications.