Clinical Research Quality Assurance Specialist III

Tekton Research is looking for a remote Quality Assurance Specialist III to join our team.

Position: Quality Assurance Specialist III (Full-Time/Exempt) 

The Quality Assurance (QA) Specialist III is a senior-level professional responsible for leading and advancing quality assurance efforts across a clinical research site network. This role involves overseeing complex audits, driving process improvement initiatives, managing compliance risks, and serving as a key resource for regulatory readiness. The QA Specialist III acts as a subject matter expert (SME) in clinical research compliance, providing strategic guidance to ensure the integrity of clinical trials and alignment with regulatory requirements.

Reports to: Quality Assurance Manager 

Job Description: 

• Conduct in-depth internal audits of clinical research activities, including investigator site files, informed consent processes, source documentation, and data integrity.
• Evaluate compliance with GCP, ICH guidelines, FDA/EMA regulations, and sponsor requirements.
• Oversee inspection readiness activities, including mock inspections, and act as a QA representative during regulatory inspections.
• Identify, evaluate, and manage quality risks across the site network, prioritizing areas for mitigation.
• Develop and oversee quality improvement plans to address systemic risks.
• Lead root cause analyses and the development of complex Corrective and Preventive Action (CAPA) plans.
• Monitor CAPA implementation, ensure effectiveness, and report outcomes to senior leadership.
• Design and implement site-wide quality improvement initiatives, ensuring alignment with industry best practices.
• Develop and update Standard Operating Procedures (SOPs), work instructions, and quality manuals.
• Provide QA team members and clinical staff with advanced quality assurance, regulatory compliance, and auditing training.
• Mentor junior and mid-level QA professionals, supporting their development and growth within the organization.
• Act as a subject matter expert in regulatory requirements, providing guidance to clinical operations, regulatory affairs, and other stakeholders.
• Collaborate with internal and external stakeholders to address quality-related issues and ensure trial integrity.
• Prepare comprehensive audit reports and executive summaries for leadership review.
• Analyze quality metrics to identify trends, opportunities for improvement, and areas of excellence.
• Other duties as assigned

Required Skills/Abilities: 

• In-depth knowledge of GCP, FDA/EMA regulations, ICH guidelines, and clinical trial processes.
• Excellent written and oral communication, attention to detail, organizational and planning skills
• Ability to perform and maintain quality work while prioritizing and managing multiple deadlines
• Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint) 
• Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), or similar platforms.
• Proven ability to conduct audits and prepare detailed audit reports.
• Demonstrated experience leading audits and managing regulatory inspections.

Education and Experience: 

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field (Master’s degree preferred).
• 5–7 years of experience in quality assurance, clinical research, or regulatory compliance, with significant experience in a QA leadership role.
• Experience working in a multi-site clinical research organization or network.

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer 
• Approximately 50% travel, with the possibility of increased travel during peak periods or as project needs demand.
• Must be able to lift to 15 pounds at times