Research Associate - Study Start-Up and Maintenance

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 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 we decide which benefits best suit your needs.