Sr Clinical Quality Assurance Analyst - Remote US

Sarah Cannon Research Institute • Usa, TN

5d • Remote

About The Position

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 Sr Clinical Quality Assurance Analyst is responsible for supporting technology solutions provided by Genospace ensuring compliance with SOPs, FDA guidelines, ICH-GCP standards, and applicable regulatory requirements. Key responsibilities include supporting the Quality Management System, contributing to the development of risk-based quality processes, monitoring key quality metrics and indicators, and assisting with quality issue investigations and escalations. The individual will also support audit and inspection readiness and interface with regulatory agencies. This is a remote position based in the US; relocation assistance and visa sponsorship are not available. 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 750 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 today. SCRI’s research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 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.

Requirements

• Bachelor’s degree in Science, Engineering, Life Sciences, Clinical Research, Quality Assurance or related field required; advanced degree preferred.
• 7+ years of progressive experience in clinical research quality assurance or regulatory monitoring with demonstrated expertise in leading complex quality initiatives.
• 5+ years of quality assurance and oversite of clinical software.
• Proficient in applying risk-based approaches to software validation, ensuring compliance with regulatory requirements and industry expectations.
• Recognized expertise in FDA guidelines, ICH-GCP principles, and applicable regulatory requirements.
• Proven ability to influence and achieve results through collaboration in a matrixed environment.
• Strong understanding of compliance frameworks and risk-based quality management.

Responsibilities

• Lead and support Research Quality activities to ensure adherence to policies and procedures, ICH-GCP, FDA guidelines, and applicable local/federal regulations.
• Contribute to the development and maintenance of policies, procedures, and controlled documents for Research Quality and supporting business units.
• Assist in implementing risk-based quality support structures and tools to monitor compliance and performance.
• Deliver training on quality assurance initiatives, regulatory compliance, and industry best practices.
• Foster a culture of continuous improvement, patient safety, and data integrity.
• Provide leadership in managing and sustaining robust document and change control programs.
• Lead research quality processes to ensure compliance with SOPs, ICH-GCP, and local/federal regulations.
• Serve as key subject matter expert and point of escalation with internal and external customers on all investigations and quality related issues.
• Assist with preparation for external audits, inspections, and quality oversight activities.
• Support communication with sponsors and regulatory agencies as directed.
• Contribute to inspection readiness activities and maintain compliance documentation.
• Other duties as assigned

Benefits

• Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being.
• Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.
• Competitive compensation package.
• Annual bonus or long-term incentive opportunities may be offered.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level