GCP Clinical Auditor II (remote US)
Core
Lead and perform complex internal and external audits to ensure compliance with GCP, quality assurance processes, and regulatory guidelines for clinical research projects.
Role type
Senior IC clinical auditor
Builds
Audit reports, compliance strategies, and quality support for clinical projects
Domain
Clinical research / Pharmaceutical / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP knowledge, root cause analysis, audit leadership, risk assessment, conflict management, written communication, verbal communication
Preferred skills
Regulated industry audit experience, clinical research or pharmaceutical background
Technologies
Standard office equipment and technology
Responsibilities
Conduct and lead client, internal, and GCP audits; Lead directed clinical site and facility audits; Provide GCP consultation and quality support; Prepare and present audit findings at meetings
Seniority
Mid-level, hands-on IC
