Principal GCP Quality Assurance Auditor
Posted 2025-03-14
Remote, USA
Full-time
Immediate Start
Description:
? Precision for Medicine is a global precision medicine clinical research services organization.
? The Principal Quality Auditor provides senior oversight and subject matter expertise to quality and compliance activities.
? Essential functions include serving as a subject matter expert and supporting project teams during all stages of clinical studies.
Requirements: ? 5 years of experience ? Working knowledge of GCP/ICH guidelines and FDA regulations and standards ? Audit experience conducting a variety of audit types, including internal systems, vendors, TMF and investigator site audits. ? 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 ? CRO, Pharmaceutical and/or Medical device experience preferred ? QA certification preferred (e.g., CQA, SQA, etc.) ? Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)
Benefits:
? Discretionary annual bonus
? Health insurance
? Retirement savings benefits
? Life insurance and disability benefits
? Parental leave
? Paid time off for sick leave and vacation
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