Clinical QA Specialist II

The Clinical Quality Specialist will own data quality generated in Loyal’s pre-clinical and clinical studies. They are responsible for implementing quality assurance and quality control processes to ensure 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 (e.g. biostatistics, clinical operations and regulatory affairs). Because Loyal’s clinical studies are long and complex, the Clinical Quality Specialist will be responsible for assisting in building and implementing systems that maximize integrity of data throughout years long studies and prepare the data for the most efficient turn around to analysis and final study report (FSR) writing at study conclusion. The role will support primarily, but not exclusively, clinical operations and biostatistics teams to ensure that our clinical trials maximize retention of as much of the hard-earned data as possible.