Clinical Research Associate II, Study Start-Up & Maintenance

Your responsibilities site and project coordination: act as the main point of contact for clinical sites throughout the study lifecycle, providing support for site initiation, compliance, and regulatory documentation, country-specific ICF customization for Poland, collection and quality review of essential documents required for EU CTR Part II and Ethics Committee submissions (initial submissions and subsequent modifications throughout the study lifecycle), preparation and QC of regulatory green light packages, tracking in CTMS and filing in eTMF, support of site feasibility activities and site outreach in the local language, support of site contract and budget negotiations with Polish sites, collaboration with internal study teams to ensure timely site activation. What we offer: remote work opportunities, professional development in a well‑established company with a strong market position, employment in a company awarded the Top Employer 2026 certificate – we create a work environment based on trust, collaboration, and diversity, a comprehensive benefits package in the form of a cafeteria system – you decide which benefits best suit your needs. Our requirements previous Study Start-Up experience (3+) in Poland within a CRO, sponsor, or similar clinical research environment, strong knowledge of EU CTR/CTIS processes and country-specific regulatory requirements in Poland, experience supporting interventional clinical trials (observational studies only is not sufficient), fluency in Polish and English, both written and spoken, strong organizational skills and ability to manage multiple studies simultaneously, used to be in direct client contact, start-up experience in other countries – nice to have , experience with IVD and/or medical device studies – nice to have.