Clinical Research Associate / CRA – home-based, Poland

Alcedis; Warszawa; Remote; PLN 83,000 - 124,000; Part time

Benefits offered by this job

Flexible working

Home-based

Job summary

Alcedis is seeking an experienced Freelance Clinical Research Associate (CRA) to join an international NIS project in Poland on a B2B basis. You will oversee approximately 15 study sites, ensure quality, and contribute to submissions and site management under the guidance of a global project team.

You should have 5+ years of CRA experience in GCP-compliant clinical research, with fluency in Polish and English.

Qualifications

• 5+ years of CRA experience in a GCP-compliant clinical research setting.
• Experience with multinational non-interventional studies.
• Proficiency with English-language study documentation.
• Solid knowledge of Polish regulatory requirements and submissions.
• Independent, proactive, well-organised with clear prioritisation.

Responsibilities

• Study organization, monitoring visits (on-site and remote) and site management.
• Support quality and compliance through source data verification and audits.
• Coordinate data management queries with the team.
• Provide EDC training and collaborate with international project team.
• Handle submissions, regulatory interactions and site contract management in Poland.
• Frequent nationwide travel to study sites.

Skills

CRA experience

GCP knowledge

Interventional trials (adv)

English documentation

Polish fluency

Travel readiness

Job description

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
• You communicate confidently and with commitment, even on critical topics. You clearly represent requirements while building trusting relationships with investigators and site staff.
• You are fluent in Polish and English, both written and spoken
• You live in Poland and are happy to travel regularly to sites nationwide

What we offer

• An engagement on a freelance basis (B2B) of approx. 85 hours per month for around 10 months
• A varied role with a high degree of responsibility and independence
• Collaboration with an experienced, international project team
• Flexible, home-based working

For more information about our company, please visit our website at Alcedis | Digital Clinical Trials.