Demonstrates extensive experience in Clinical Research Associate (CRA) roles, managing non-interventional studies and site contracts in Poland, while ensuring compliance with local regulatory requirements. Proficient in English and Polish, with strong communication and organizational skills to effectively coordinate with international project teams and site staff.

Highest-signal resume keywords

5+ Years Experience As A CRAGCP ComplianceSite ManagementFluent In Polish And EnglishKnowledge Of Local Regulatory Requirements

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support the Clinical Operations team in an international non-interventional study (NIS)
Independently manage approximately 15 study sites throughout Poland
Act as the local point of contact for the international project team
Conduct site qualification and feasibility, site management, initiation, monitoring and close-out visits on-site and remotely
Prepare visit reports
Perform source data verification and support site audits and inspections
Manage queries in collaboration with data management and project management
Provide EDC training for site staff
Coordinate with the international project team
Handle submissions and notifications to Ethics Committees and, where required, local authorities
Interact with local regulatory authorities
Manage site contracts in Poland
Travel regularly to study sites across Poland

Requirements

What you’ll need

5 or more years of experience as a CRA in GCP-compliant clinical research in the industry (e.g. CRO, pharma or biotech)
Experience working on multinational non-interventional studies
Experience with interventional clinical trials is an advantage
Confident working with English-language study documentation, including protocols, monitoring plans, manuals and eCRF guidelines
Knowledge of local regulatory requirements in Poland
Hands-on experience with submissions, interactions with local authorities and site contract management
Independent, proactive and conscientious approach to work
Reliable planning and organization skills, ability to set clear priorities and manage complex situations
Confident communication skills, including handling critical topics and building relationships with investigators and site staff
Fluent in Polish and English, written and spoken
Must live in Poland and be willing to travel regularly to sites nationwide

Benefits

Comp & perks

Freelance (B2B) engagement of approximately 85 hours per month for around 10 months
Varied role with a high degree of responsibility and independence
Collaboration with an experienced, international project team
Flexible, home-based working

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site QualificationFeasibility AssessmentSource Data VerificationEDC TrainingSubmissions To Ethics CommitteesSite Contract ManagementMonitoring PlansECRF GuidelinesInterventional Clinical TrialsNon-Interventional Studies

Soft Skills

Independent ApproachProactive AttitudeReliable PlanningOrganizational SkillsConfident Communication

Industry Keywords

Clinical ResearchCROPharmaBiotechInternational Project Coordination