Clinical QA Auditor - Remote US

**It’s More Than a Career, It’s a Mission.** Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community\-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission\-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. **Our Mission** People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting\-edge research, SCRI is redefining cancer care around the world. Our **Quality Assurance Auditor** will be responsible for promoting the development and implementation of quality initiatives within SCRI through conduct of audits. **This is a remote position based in the US; relocation assistance and visa sponsorship are not available.** **Duties include and are not limited to:** * Plans and conducts GxP audits (e.g., internal, vendor, site) * Develop a risk\-based audit plan to determine the priorities of audit activities * Conducts interviews with key staff to assess process completion, support inspection readiness and to communicate any potential observations or process improvement opportunities * Communicates audit observations and process improvement opportunities through a written audit report distributed to the appropriate personnel * Appropriately escalates any critically identified areas of deficiency in quality and reports those to organization leadership and other appropriate stakeholders * Tracks, collects and reviews audit responses for timely and appropriate corrective action as follow\-up to identified areas of non\-compliance until audit closure * Other duties as assigned. **Qualifications for success in this role include** : * Bachelors Degree required * 3\+ years' work experience in a regulated clinical research environment required; Quality Assurance Auditing experience required * Work experience with FDA regulations and GCP is required. * Knowledge of 21 CFR Part 11 requirements and software validation principles * Certified SQA Professional, RQA\-Certified Quality Auditor or equivalent highly preferred. **About Sarah Cannon Research Institute** Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community\-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country.