About the job
Senior Clinical Research Associate – Poland
Chloe O’Shea is proud to partner with a leading global CRO renowned for delivering innovative, high-quality solutions in clinical development. We are seeking an experienced Senior Clinical Research Associate (Senior CRA) to join a dedicated single-sponsor team in Poland. This is an exciting opportunity to work on cutting-edge studies, with a particular focus on advanced therapy areas such as CAR-T and gene therapy. While prior experience in these fields is highly valued, it is not essential — full training and support will be provided.
The Role
As a Senior CRA, you will be a key contributor to the successful delivery of clinical trials across Poland. You will oversee site management activities, act as a primary liaison with investigative sites, and ensure strict compliance with protocols, ICH-GCP, and Polish regulatory requirements. This role is ideal for ambitious CRAs ready to step up or established Senior CRAs seeking to deepen their expertise in innovative therapy areas.
Key Responsibilities
- Independently manage qualification, initiation, monitoring, and close-out visits across Poland.
- Ensure high standards of compliance with ICH-GCP, local regulatory requirements, and sponsor SOPs.
- Perform source data verification, investigational product accountability, and ensure accurate site documentation.
- Serve as a trusted partner to site personnel, offering training, guidance, and ongoing support.
- Identify site-level challenges proactively and drive timely resolution.
- Contribute to mentorship of junior CRAs and share best practices within the monitoring team.
- Maintain complete and accurate trial documentation in CTMS, eTMF, and EDC systems.
Requirements
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
- Minimum 5 years of independent monitoring experience in Poland or Central/Eastern Europe, ideally with exposure to complex studies.
- Experience in CAR-T / cell and gene therapy
- Strong knowledge of ICH-GCP and Polish clinical trial regulations (e.g., UOD, local Ethics Committees).
- Excellent communication, relationship-building, and organisational skills.
What’s in It for You?
This role offers a competitive salary and benefits package, flexible working arrangements, and clear opportunities for career progression within one of the world’s largest CROs. You’ll gain exposure to innovative therapies shaping the future of healthcare while working in a collaborative culture that values professional development, work-life balance, and wellbeing.
If you are a driven Senior CRA — or an experienced CRA ready to take the next step — we’d love to hear from you. Apply today to join a global team making a meaningful difference in patients’ lives.