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Clinical Research Qa Jobs (NOW HIRING)

OneOncology

Manager, Research Quality

Charleston, WV

Contribute to network-wide training programs on quality assurance, regulatory compliance, and best practices in clinical research; deliver training. Other duties as assigned to help drive our mission ...

OneOncology

Manager, Research Quality

Nashville, TN · On-site

Required or Preferred Qualifications: • 4-8+ years of experience clinical research quality assurance, regulatory compliance, training and education. • Bachelor's degree required, advanced degree ...

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As of Sep 9, 2026, the average yearly pay for clinical research qa in the United States is $107,336.00, according to ZipRecruiter salary data. Most workers in this role earn between $81,000.00 and $122,500.00 per year, depending on experience, location, and employer.

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Clinical Research Quality Assurance Specialist III

Austin, TX • Remote

Tekton Research Inc
Scientific Research and Development Services • 11 - 50 employees
Learn more about Tekton Research Incexternal

$37.25 - $50/hr

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

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