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Clinical Trials Quality Assurance Specialist
hace 2 meses
About the Role
PSI is seeking a skilled Clinical Trials Quality Assurance Specialist to join our international team. This is an excellent opportunity to work in multiple therapeutic areas and gain exposure to all aspects of the clinical trial process.
Your Responsibilities:
- Conduct quality assurance audits, including site audits, vendor qualification audits, and internal system audits.
- Communicate with project teams regarding audit findings and resolution.
- Assemble audit documentation and maintain relevant communication with auditees.
- Train PSI Operations staff in quality management topics.
Requirements:
- A minimum of 3 years' experience in quality management or quality assurance in a clinical study environment.
- Excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations.
- Team-oriented individual with superior communication and interpersonal skills.
- Ability to travel internationally for site audits.
What We Offer:
- An estimated salary of $120,000 - $150,000 per year, depending on location and experience.
- The opportunity to work in multiple therapeutic areas and gain exposure to all aspects of the clinical trial process.
- A competitive benefits package, including health insurance, retirement plan, and paid time off.
About PSI:
PSI is a leading provider of clinical research services, committed to delivering high-quality results while fostering a culture of innovation and excellence. Our recruitment process is easy and straightforward, and we'll be there with you every step of the way.
