Senior Auditor Clinical Affairs
$99,300–$198,700 year
On-site · Lake Forest, Illinois, United States
Job Summary
Senior Auditor in Clinical Affairs responsible for planning and conducting external clinical study audits, internal specimen collection audits, clinical data verifications and master file audits; lead and mentor QA auditing staff, manage contract auditors, and support investigator training. Must maintain up-to-date knowledge of GCP, ICH, and FDA regulations; interpret and apply regulatory standards to complex systems and trials; prepare audit reports, drive CAPA and corrective actions, and support regulatory inspections. Strong organizational, interpersonal, and communication skills with proficiency in Word, Excel, and PowerPoint; travel up to 50% is expected.
Required Qualifications
- Bachelor’s Degree in biology, chemistry, microbiology, or related life sciences
- 6–8 years in Quality Assurance or clinical research
- 3–4 years in QA/GCP auditing
- Experience with paper-based data management systems as well as EDC data management systems
- Ability to investigate and analyze information and draw conclusions
- Require knowledge and training in CAPA
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