GCP QA Clinical Auditor II
Core
Conduct and lead GCP audits, regulatory inspections, and process audits to ensure clinical trial compliance and quality standards.
Role type
Senior IC Quality Assurance Clinical Auditor
Builds
Audit reports, findings, and process improvements for clinical research projects
Domain
Clinical Research / Life Sciences / Regulatory Compliance
Deliverable
client delivery
Required skills
GCP knowledge, regulatory guidelines proficiency, root cause analysis, risk assessment, audit leadership, conflict management
Preferred skills
Vendor audit experience, database audit experience, clinical study report audit experience
Technologies
Computer software (in-house and off-the-shelf)
Responsibilities
Conduct client, internal, and GCP audits; Perform site, facility, and vendor audits; Provide GCP consultation; Lead process audits; Prepare and present audit findings
Seniority
Mid-level, hands-on IC