Study Start-Up & Regulatory Research Associate — Poland

Kapadi Pty; Polska; Remote; PLN 60,000 - 90,000; Full time

Benefits offered by this job

Remote work opportunities

Professional development

Top Employer 2026 certificate

Job summary

Kapadi is a full service CRO focusing on oncology indications including immunotherapy and cellular therapies. We seek a Research Associate - Study Start-Up and Maintenance to help grow our portfolio and deliver new therapies to cancer patients.

You will coordinate sites, customize Polish ICFs, and manage regulatory submissions. Ideal candidates have 3+ years Start-Up experience in Poland, strong EU CTR/CTIS knowledge, and fluency in Polish and English.

Qualifications

• 3+ years of Study Start-Up experience in Poland within CROs, sponsors, or similar.
• Strong knowledge of EU CTR/CTIS processes and country-specific requirements in Poland.
• Experience supporting interventional trials; observational studies not sufficient.
• Fluency in Polish and English, both written and spoken.
• Strong organizational skills with ability to manage multiple studies.
• Experience in direct client contact.

Responsibilities

• Site and project coordination as main contact for clinical sites throughout study lifecycle.
• Country-specific ICF customization for Poland.
• Collection and QA of essential documents for EU CTR Part II and Ethics Committee submissions.
• Preparation and QC of regulatory green light packages.
• Tracking in CTMS and filing in eTMF.
• Support of site feasibility and outreach in local language.
• Support site contract and budget negotiations with Polish sites.
• Collaborate with internal study teams to ensure timely site activation.

Skills

Study Start-Up

EU CTR/CTIS knowledge

Interventional trials experience

Regulatory documentation

Client contact

Polish language

English language

CTMS

eTMF

Tools

CTMS

eTMF

Job description

Kapadi is a full service CRO focusing on oncology indications including immunotherapy and cellular therapies. We seek a Research Associate - Study Start-Up and Maintenance to help grow our portfolio and deliver new therapies to cancer patients.

You will coordinate sites, customize Polish ICFs, and manage regulatory submissions. Ideal candidates have 3+ years Start-Up experience in Poland, strong EU CTR/CTIS knowledge, and fluency in Polish and English.