Poland Study Start-Up & Regulatory Specialist (Remote)

Kapadi Pty; Polska; Remote; PLN 90,000 - 150,000; Full time

Benefits offered by this job

Remote work opportunities

Professional development

Top Employer 2026 certificate

Cafeteria benefits

Job summary

Kapadi is a full service CRO focusing on oncology indications, immunotherapy and cellular therapies. We are seeking a motivated Research Associate - Study Start-Up and Maintenance to help us grow and deliver new therapies for cancer patients.

The role covers site and project coordination in Poland, regulatory submissions, ICF customization for Poland, CTMS/eTMF tracking, and collaboration with internal teams to activate sites. Fluency in Polish and English is required.

Qualifications

• 3+ years in Poland within a CRO, sponsor, or similar clinical research environment.
• Strong knowledge of EU CTR/CTIS processes and country-specific requirements in Poland.
• Experience supporting interventional trials; observational studies alone are not sufficient.
• Fluency in Polish and English, both written and spoken.
• Excellent organizational skills with ability to manage multiple studies.
• Experience with direct client contact; start-up experience in other countries is a plus.
• Experience with IVD and/or medical device studies is desirable.

Responsibilities

• Site and project coordination as the main contact for clinical sites throughout the study lifecycle.
• Support for site initiation, compliance, and regulatory documentation.
• Poland-specific ICF customization.
• Collection and QC of 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 activities and site outreach in Polish.
• Support of site contracts and budgets with Polish sites.
• Collaboration with internal study teams to activate sites in a timely manner.

Skills

Study Start-Up

Polish language

English language

Regulatory knowledge

CTIS knowledge

CTMS

eTMF

Site coordination

Tools

CTMS

eTMF

Job description

Kapadi is a full service CRO focusing on oncology indications, immunotherapy and cellular therapies. We are seeking a motivated Research Associate - Study Start-Up and Maintenance to help us grow and deliver new therapies for cancer patients.

The role covers site and project coordination in Poland, regulatory submissions, ICF customization for Poland, CTMS/eTMF tracking, and collaboration with internal teams to activate sites. Fluency in Polish and English is required.