Clinical IT Quality Control Analyst - Remote US

• Bachelor's Degree required; professional qualified experience may be substituted for education.

• Direct experience in QA/QC role in computerized systems validation

• Experience in GCP clinical space, such as CRO or SMO, is highly preferred

• 3+ years' professional work experience in a clinical research, biotech, or pharmaceutical environment focused in FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines.

• Experience and knowledge of EU regulations, e.g., Annex 11 is preferred.

• Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc.

• Knowledge of pharmaceutical, biologics, CRO, and clinical sites 21 CFR Part 11 requirements and software validation principles.

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.

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