GCP Auditor, Poland

This is a fully remote position, open to applicants in Poland.

📋 Description

• Perform Good Clinical Practice (GCP) audits, which includes planning, preparing agendas, conducting physical or remote audits, and writing reports.

• Assess investigator sites, CROs, and vendors for compliance and qualification.

• Develop thorough audit reports that outline findings and root causes.

• Deliver written audit reports in English.

• Assist in implementing corrective actions and present findings to QA leadership and stakeholders as necessary.

• Collaborate with clients to uphold quality standards.

• Join Advarra's consultant network for projects based in Poland.

⛳️ Requirements

• At least 10+ years of experience in Clinical Quality Assurance and/or Good Clinical Practice (GCP).

• A minimum of 5+ years of experience in conducting Good Clinical Practices audits.

• Proven experience with the expectations of regulatory agencies, including the FDA and EMA.

• Demonstrated proficiency in audit readiness activities.

• Experienced in developing and executing quality assurance plans, audit programs, and corrective action plans.

• Proficient in Polish at a B2 level, both verbal and written.

• Proficient in English at a B2 level, both verbal and written.

• Bachelor's degree required.

• Strong interpersonal and client engagement skills.

• Exceptional analytical, problem-solving, communication, and report-writing abilities.

• Capability to collaborate across departments and interact with both internal and external stakeholders.

• Registration in Advarra's Expert Enrollment Form is necessary for candidates not already in the Network.

🏝️ Benefits

• An inclusive and collaborative work environment.

• Appreciation for diverse perspectives.

• Compassion and support for clients and clinical trial participants.

• Opportunities within the consultant network.

• Support for corrective actions and opportunities to present findings if required.