Clinical QA Specialist II Jobs

Loyal

Location:
United States

Category:
Research and Development

Contract Type:
Not provided

Salary:

75000.00 - 95000.00 USD / Year

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Job Description:

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.

Job Responsibility:

Participate in a rigorous quality control program for Loyal’s clinical team
Site visits to clinical trial sites (vet clinics) with clinical research associates (CRAs) to ensure procedural quality at the data collection source
Assist 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

Requirements:

Bachelor’s degree or equivalent experience required, preferably in animal science, biology, veterinary, or related life sciences
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 follow-up skills, as well as attention to detail
Able to travel up to 40% regionally and nationally
Working knowledge of regulations, standards, and guidances for Good Laboratory Practice and (Veterinary) Good Clinical Practice
Proficiency in electronic data capture systems and study drug inventory management systems
Ability to analyze complex problems and develop multiple solutions within regulatory guidance

What we offer:

Full-coverage health insurance — medical, dental and vision — for you and your dependents
$1,000 home office equipment stipend
$1,200/year learning budget for books, courses, etc.
$250/month wellness budget for gym, cleaners, spa, food, etc.
All 3-day weekends are turned into 4-day weekends
Unlimited vacation and paid holidays
Paw-ternity leave — adopt a dog and get a day off with your new family member
Competitive salary
Company equity options grant for new hires

Additional Information:

Job Posted:
December 10, 2025

Employment Type:

Fulltime

Work Type:

Remote work

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Clinical QA Specialist II