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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in Good Clinical Practice (GCP) auditing and Clinical Quality Assurance, with a strong focus on compliance, regulatory agency expectations, and quality assurance plan development. Proficient in report writing and effective communication in both Polish and English.
Highest-signal resume keywords
Good Clinical Practice (GCP) AuditingClinical Quality AssuranceRegulatory Agency Compliance (FDA, EMA)Audit Readiness ActivitiesQuality Assurance Plan Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
GCP AuditsAudit Report WritingCompliance EvaluationCorrective Action PlansQuality Assurance PlansAnalytical SkillsProblem-Solving Skills
Soft Skills
Interpersonal SkillsClient Interaction SkillsCollaboration SkillsCommunication Skills
Industry Keywords
Clinical TrialsCROsAudit ProgramsStakeholder EngagementAdvarra Consultant Network
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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
