GCP Auditors for Turkey-based projects ensuring compliance in clinical trials by conducting audits and preparing reports. Collaborating with clients and presenting findings to stakeholders.
Responsibilities
Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing)
Evaluate investigator sites, CROs, and vendor compliance or qualification.
Prepare comprehensive audit reports detailing findings and root-causes.
Provide written audit reports in English.
If required will provide corrective actions support and present findings to QA leadership and stakeholders
Work collaboratively with clients to ensure quality standards.
Requirements
Minimum 10+ years of Clinical Quality Assurance and/or Good Clinical Practice (GCP) experience.
Minimum 5+ years of Good Clinical Practices auditing experience.
Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
B2 level in English communication, verbal and written
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