About Axcellant
Axcellant is a boutique Clinical Research Organization supporting pharma, biotech, and innovative sponsors in the execution of complex, high-impact clinical trials—including oncology, rare diseases, radiopharmaceuticals, advanced diagnostics, and other demanding study designs.
We combine senior-level involvement, operational agility, and scientific depth with a pragmatic, partner-driven approach. As we scale our commercial footprint in Europe and beyond, we are looking for a Business Development Manager who can help shape our growth trajectory—not just execute a sales plan.
This role is ideal for someone who thrives in lean, high-ownership environments, understands how sponsors buy CRO services, and is motivated by building something meaningful rather than selling at scale.
The Role
As Clinical Research Associate, you will be responsible for the monitoring and site management of clinical trials conducted in Poland, ensuring subject safety, data integrity, protocol compliance, and high-quality site performance across the study lifecycle.
You will independently manage investigative sites and act as a key liaison between sites, sponsors, and internal teams. This is a hands-on role for an experienced CRA who can combine strong field execution with mature judgment in complex IMP and medical device studies.
Key Responsibilities
- Conduct and document site qualification, initiation, routine monitoring, and close-out visits in Poland
- Perform local site management activities to ensure compliance with protocol, ICH-GCP, sponsor requirements, and applicable regulations
- Review source documentation and verify data quality, completeness, and accuracy
- Support sites in study procedures, protocol adherence, recruitment, documentation, deviation handling, and issue resolution
- Ensure regulatory, essential, and site files are accurate, complete, and inspection-ready
- Identify risks, compliance gaps, and operational challenges early, and escalate appropriately with proposed solutions
- Build strong working relationships with investigators, study coordinators, pharmacists, and site teams
- Contribute to site activation readiness and ongoing performance management
- Collaborate closely with project managers, study start-up, regulatory, safety, and data management teams
- Support sponsor-facing communication through clear reporting, timely follow-up, and reliable local insight
What We’re Looking For
- Minimum 3 years of local monitoring experience in Poland as a CRA in clinical trials
- Strong independent monitoring background across both IMP and medical device studies
- Proven experience managing Polish sites through initiation, monitoring, and close-out phases
- Strong knowledge of ICH-GCP, site management, source data verification, and essential-document oversight
- Solid understanding of local and international clinical trial regulations and operational requirements
- Fluency in Regulatory Affairs relevant to site-level and study-level execution
- Experience in oncology, rare disease, advanced diagnostics, or other complex protocols is a strong plus
- Strong written and verbal communication skills in Polish and English
- Excellent organizational skills, attention to detail, and ability to work independently in a field-based environment
- Willingness to travel within Poland as required by study needs
What We Offer
- An opportunity to work on complex, high-impact clinical trials in a boutique CRO setting where expertise matters
- Direct collaboration with senior clinical leaders and sponsors
- High level of trust, autonomy, and operational ownership
- Exposure to scientifically demanding studies, including innovative therapies and medical technologies
- Competitive compensation and a flexible working model
- A role where your local expertise has visible impact on study quality and delivery