Research Associate - Study Start-Up and Maintenance

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 that focuses on complex oncology indications including immunotherapy and cellular therapies. We know that innovative research requires innovative operations and we've built that into our culture, systems and processes. We have an infrastructure to enhance access to patients and integrated technology to provide higher quality and faster access to results. We are looking for a highly-motivated Research Associate - Study Start-Up and Maintenance to help us continue to grow our business and deliver new, life-changing therapies for the cancer patients who need them.

Your responsibilities

• site and project coordination: act as the main point of contact for clinical sites throughout the study lifecycle, providing support for site initiation, compliance, and regulatory documentation.
• country-specific ICF customization for Poland.
• collection and quality review of essential documents required for EU CTR Part II and Ethics Committee submissions (initial submissions and subsequent modifications throughout the study lifecycle),
• preparation and QC of regulatory green light packages.
• tracking in CTMS and filing in eTMF.
• support of site feasibility activities and site outreach in the local language.
• support of site contract and budget negotiations with Polish sites.
• collaboration with internal study teams to ensure timely site activation.

Our requirements

• previous Study Start-Up experience (3+) in Poland within a CRO, sponsor, or similar clinical research environment,
• strong knowledge of EU CTR/CTIS processes and country-specific regulatory requirements in Poland.
• experience supporting interventional clinical trials (observational studies only is not sufficient),
• fluency in Polish and English, both written and spoken.
• strong organizational skills and ability to manage multiple studies simultaneously.
• used to be in direct client contact.
• start-up experience in other countries - nice to have.
• experience with IVD and/or medical device studies - nice to have.

What we offer:

• remote work opportunities,
• professional development in a well-established company with a strong market position,
• employment in a company awarded the Top Employer 2026 certificate - we create a work environment based on trust, collaboration, and diversity.
• a comprehensive benefits package in the form of a cafeteria system - you decide which benefits best suit your needs.