Clinical Research Associate / CRA – home-based, Poland

Alcedis is a well-established clinical research organization headquartered in Germany, with over 30 years of experience in managing clinical studies. For an international study we are currently preparing, we are looking for an experienced clinical research professional in Poland to join our project team on a freelance (B2B) basis for the duration of the project.

As a Freelance CRA, you will support our Clinical Operations team in an international non-interventional study (NIS). You will oversee and ensure quality standards at study sites across Poland and contribute to the successful conduct of the study.

You will independently manage approximately 15 study sites throughout Poland and act as our local point of contact, working closely with our international project team, with project management based in Germany. Beyond classic monitoring, you will also take responsibility for submissions and notifications for the study (e.g. to Ethics Committees and, where required, local authorities) and site contract management in Poland. The engagement is planned for approximately 10 months with an average workload of around 85 hours per month. The ideal start date is 1 December 2026, and an earlier start in November is possible. The project runs until Q3 2027.

What you’ll do

• Study organization & monitoring: Site qualification/feasibility, site management, as well as initiation, monitoring and close-out visits on-site and remotely, including visit reports
• Quality & compliance: Source data verification and support of audits and inspections at the sites
• Data management & queries: Query management in close collaboration with data management and project management
• Training & collaboration: EDC training for site staff and coordination with the international project team
• Submissions, regulatory & contracts: Submissions and notifications, interactions with local regulatory authorities and site contract management in Poland
• Travel: Regular site visits across Poland

Who you are

• You have 5 or more years of experience as a CRA in GCP-compliant clinical research in the industry (e.g. CRO, pharma or biotech)
• You have worked on multinational non-interventional studies and enjoy collaborating with international project teams. Experience with interventional clinical trials is an advantage
• You are confident working with English-language study documentation, such as protocols, monitoring plans, manuals and eCRF guidelines
• You know the local regulatory requirements in Poland well and have hands-on experience with submissions, interactions with local authorities and site contract management.
• You approach your work independently, proactively and conscientiously. You plan and organize reliably, set clear priorities and keep the overview even in complex situations, always finding pragmatic solutions