GCP Auditor
Remote
Job Summary
Conduct routine GCP audits, including investigator site, trial master file, vendor, and internal audits of quality systems. Support project teams with QA consultation, manage reported quality issues and corrective and preventive actions, and monitor quality systems to identify compliance risks. Host client and sponsor audits, participate in computer systems validation projects, and maintain Q&C trackers, databases, and metrics. Ensure adherence to local regulations, ICH, and FDA standards while developing and administering training for employees and consultants. This role requires extensive experience managing audits in clinical trials environments and availability to travel up to 25% domestically and/or internationally.
Required Qualifications
- extensive, working knowledge of managing audits in Clinical Trials environment: routine GCP audits, CRO process audits, Vendor Audits
- Working knowledge of GCP/ICH guidelines and FDA regulations and standards
- Bachelor's degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative
- Availability to travel up to 25% domestically and/or internationally
Desired Qualifications
- 2 or more years' experience in QA GCP department in a related industry
- QA certification preferred (e.g., CQA, SQA, etc.)
- Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)
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