Clinical QA Specialist II

About Loyal

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.

We’ve already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year.

Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.

About the role

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. 

You will be reporting to our Director of Clinical Quality.

Your daily work will include:

• Participate in a rigorous quality control program for Loyal’s clinical team and, where appropriate, collaborating with operational quality to integrate processes within the company quality system. 
• Site visits to clinical trial sites (vet clinics) with clinical research associates (CRAs) to ensure procedural quality at the data collection sourceAssist in maintaining and organizing quality management system (QMS) documentation, including SOPs, CAPAs, and training records. Provide/support GCP guidance on questions arising from day to day clinical trial activities. Support clinical teams with quality-related questions, document requests, and system access. 
• Identifying discrepancies and inconsistencies in data collection and, if necessary, providing remediation or training to the clinical operations team.
• Working closely with CRAs to standardize data collection methods and quality processes from site initiation through study close out. 
• Utilize guidance documents and standards to interpret for guidance, ensuring quality and compliance to regulations.
• Support preparation for internal and external audits, including vendor and site audits.
• Help track and follow up on audit findings, deviations, and corrective/preventive actions (CAPAs).
• Assist in development of risk based, efficient audit plans at the study and site level.
• Partner with clinical team for risk identification, management, and mitigation activities.
• Oversight of deviation root cause analysis and CAPA development for pre-clinical and clinical studies.
• Participate in document control and review processes to ensure version control and compliance with GCP standards.
• Operating within electronic data capture systems and study drug inventory management systems (such as IWRS) to navigate large numbers of study subjects and ensure consistency and management of data across study sites.
• Performing user acceptance testing of electronic data capture builds specific for each clinical study.
• Own inspection readiness programs pertaining to pre-clinical and clinical studies
• Implementation of quality plans.
• Help develop and distribute training materials related to GCP, SOPs, and quality systems.
• Maintain quality metrics dashboards and assist with reporting to management.
• Stay informed about changes in regulations and quality best practices in clinical research.

About you: 

• Bachelor’s degree or equivalent experience required, preferably in animal science, biology, veterinary, or related life sciences. Equivalent experience can be a veterinary technician, veterinary clinical assistant, veterinary coordinator or the like.
• 3+ years experience in GCP animal health studies (non human health studies), clinical development or operations, or QA.
• Excellent communication, presentation, and interpersonal skills.
• Exceptional organizational and