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. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here . As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind: McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application. McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates. McKesson job postings are posted on our career site: careers.mckesson.com . We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.