Clinical QA Specialist II

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November 20

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Loyal

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Healthcare Insurance • Artificial Intelligence • SaaS

Loyal is a comprehensive digital healthcare platform that integrates various touchpoints for patients and providers. Their solutions include data management, digital engagement, CRM campaigns, self-scheduling, and conversational AI, which are designed to optimize healthcare operations, improve patient engagement, and enhance care search and scheduling. Loyal focuses on making healthcare seamless by unifying provider and location data, managing reputation and directory listings, and offering robust machine learning and natural language processing capabilities to improve healthcare outcomes. The platform facilitates improved communication and retention through omni-channel engagement and feedback analysis, serving prominent healthcare organizations to streamline operations and drive better patient experiences.

51 - 200 employees

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

☁️ SaaS

📋 Description

• 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.

🎯 Requirements

• 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 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.

🏖️ Benefits

• 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