Clinical Trials Quality Assurance Specialist
hace 4 días
Job Overview
PSI is seeking a highly skilled Clinical Trials Quality Assurance Specialist to join their team. This role will involve ensuring high-quality standards within clinical trials and internal company processes.
Key Responsibilities
- Planning, conducting, and reporting of QA audits
- Communicating with project teams regarding QA study audits
- Assembling QA audit documentation
- Training PSI Operations staff in quality management topics
About the Role
The ideal candidate will have a minimum of 3 years' experience in quality management or quality assurance in a clinical study environment. They should also have excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations.
Requirements
- M.D., PharmD, or degree in life sciences preferred
- Full working proficiency in English required
- Proficiency in MS Office applications necessary
- Able to travel for site audits
Benefits and Compensation
The estimated salary for this role is $80,000-$100,000 per year, depending on location and experience. In addition to a competitive salary, PSI offers a range of benefits, including professional development opportunities and a supportive work environment.
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