GCP Auditor, Poland

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🔥 25 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🔎 Auditor

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Advarra

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1983

💼 Consulting

📦 Logistics

📣 Marketing

Consulting • Logistics • Marketing

Advarra is a provider of integrated technology and services for clinical research, combining institutional review and compliance services with software platforms to support the full clinical trial lifecycle. The company offers ethics review services (IRB, IBC, DMC, endpoint adjudication), site enablement and research staffing, and a suite of cloud products — including eRegulatory, eConsent, eSource/EDC, CTMS and study design tools — plus an AI-powered operational intelligence engine (Braid) to streamline trial start-up, enrollment, and operations. Advarra serves sponsors, CROs, research sites, and institutions with a focus on patient protection, regulatory compliance, and accelerating trial outcomes.

📋 Description

• Conduct Good Clinical Practice (GCP) audits, including planning, agenda preparation, physical or remote audits, and report writing • Evaluate investigator sites, CROs, and vendors for compliance or qualification • Prepare comprehensive audit reports detailing findings and root causes • Provide written audit reports in English • Support corrective actions and present findings to QA leadership and stakeholders when required • Work collaboratively with clients to ensure quality standards • Join Advarra's consultant network for Poland-based projects

🎯 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, including FDA and EMA • Demonstrated experience in audit readiness activities • Demonstrated experience developing and implementing quality assurance plans, audit programs, and corrective action plans • B2 level Polish communication, verbal and written • B2 level English communication, verbal and written • Bachelor's degree • Strong interpersonal and client interaction skills • Excellent analytical, problem-solving, communication, and report-writing skills • Ability to work collaboratively across departments and interact with internal and external stakeholders • Registration in Advarra's Expert Enrollment Form is required for candidates not already in the Network

🏖️ Benefits

• Inclusive and collaborative work environment • Respect for diverse perspectives • Empathy and care for clients and clinical trial participants • Consultant network opportunities • Corrective actions support and presentation opportunities, if required

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