Clinical QA Specialist II

The Clinical Quality Specialist will own data quality generated in Loyal’s pre-clinical and clinical studies and implement quality assurance and quality control processes. They are responsible for ensuring studies are conducted and data are generated, documented, and reported in compliance with applicable protocols, GLP, GCP, and regulatory requirements. The Clinical Quality Specialist will participate in quality initiatives, collaborating with cross functional teams, primarily clinical operations and biostatistics teams. Daily work will include participating in a quality control program, site visits to clinical trial sites, maintaining quality management system documentation, providing GCP guidance, supporting clinical teams with quality-related questions, identifying discrepancies in data collection, supporting internal and external audits, and participating in document control processes. Bachelor’s degree or equivalent experience required. Must be able to travel up to 40%.