Clinical Research Associate / CRA – home-based, Poland

Alcedis

5d•Remote

About The Position

Alcedis is seeking an experienced clinical research professional based in Poland to support its Clinical Operations team on an international non-interventional study. On a freelance (B2B) basis, the CRA will independently manage approximately 15 study sites across Poland and serve as the local point of contact, working closely with an international project team whose project management is based in Germany. The role includes oversight of site quality and study conduct, as well as responsibility for Polish study submissions and notifications and site contract management. The engagement is planned for approximately 10 months, averaging around 85 hours per month, with the project running until Q3 2027. The ideal start date is 1 December 2026, although an earlier start in November is possible. The role is home-based and involves regular travel to sites throughout Poland.

Requirements

At least 5 years of experience as a CRA in GCP-compliant clinical research in industry, such as a CRO, pharmaceutical company, or biotechnology company.
Experience working on multinational non-interventional studies and collaborating with international project teams.
Confident working with English-language study documentation, including protocols, monitoring plans, manuals, and eCRF guidelines.
Strong knowledge of Polish local regulatory requirements and hands-on experience with submissions, interactions with local authorities, and site contract management.
Independent, proactive, and conscientious approach to work.
Reliable planning and organization, ability to prioritize and maintain oversight in complex situations, and pragmatic problem-solving skills.
Confident and committed communication, including on critical topics, with the ability to clearly represent requirements while building trusting relationships with investigators and site staff.
Fluent written and spoken Polish and English.
Lives in Poland and is willing to travel regularly to sites nationwide.

Nice To Haves

Experience with interventional clinical trials.

Responsibilities

Conduct site qualification and feasibility activities and manage study sites.
Perform site initiation, monitoring, and close-out visits both on-site and remotely, including preparation of visit reports.
Oversee quality and compliance, including source data verification and support for site audits and inspections.
Manage queries in close collaboration with data management and project management.
Provide EDC training to site staff and coordinate with the international project team.
Prepare and manage study submissions and notifications, interact with local regulatory authorities, and manage site contracts in Poland.
Travel regularly to study sites throughout Poland.