Note: The job is a remote job and is open to candidates in USA. FDAQRC is a quality consulting firm that provides regulatory compliance and quality assurance solutions to pharmaceutical, medical device, and biotech companies. The Good Clinical Practice Auditor conducts audits, reviews protocols and study reports, produces audit reports, and maintains knowledge of relevant regulations.
Responsibilities
- The Good Clinical Practice Auditor will be responsible for conducting audits to ensure that they comply with Good Clinical Practice (GCP) guidelines and other applicable regulations
- Day-to-day tasks include reviewing protocols and study reports, conducting on-site or remote audits, and producing audit reports
- The Good Clinical Practice Auditor will also be responsible for maintaining current knowledge of relevant regulations
Skills
- At least three
- Broad knowledge of applying relevant regulations to the task
- Excellent communication skills, both written and verbal
- Understanding of medicine and clinical research principles
- Knowledge of Good Clinical Practice guidelines and other relevant regulations
- Experience conducting audits
- Experience providing training in GCP
- Ability to conduct research and analyze data
- Bachelor's degree in a related field, such as life sciences, healthcare, or regulatory affairs
- Five years preferred
- Certifications in relevant areas, such as GCP, regulatory affairs, or quality assurance
Benefits
- Full-time remote role
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