Clinical Start-Up Specialist (Poland) — CA & EC Submissions

Resourcing Life Science Ltd.; Polska; On-site; PLN 60,000 - 90,000; Full time

Job summary

Resourcing Life Science Ltd. in Poland is seeking a Start up Specialist for a Global CRO to support CA & EC submissions across studies and ensure regulatory readiness.

You will prepare site contracts, translate documents for submissions and maintain up-to-date knowledge of GCP/ICH guidelines while supervising study conduct in compliance with applicable laws. Fluent English and Polish, a life-science degree, and 1 year in EC/CA submissions are required.

Qualifications

• Bachelor degree in life-science required.
• Min 1 year EC & CA submissions experience in Poland CRO/Pharma.
• Clinical studies phase II-III experience.
• Fluent in English and Polish.
• Excellent communication skills.

Responsibilities

• Responsible for CA & Ethics Committee submission.
• Prepare & negotiate site contracts for assigned studies.
• Keep up to date with GCP and ICH guidelines for clinical research.
• Translate and coordinate translations for submission documents.
• Supervise study conduct according to GCP and applicable laws.

Skills

Excellent communication skills

Fluent English

Fluent Polish

Education

Bachelor degree in life-science

Job description

Resourcing Life Science Ltd. in Poland is seeking a Start up Specialist for a Global CRO to support CA & EC submissions across studies and ensure regulatory readiness.

You will prepare site contracts, translate documents for submissions and maintain up-to-date knowledge of GCP/ICH guidelines while supervising study conduct in compliance with applicable laws. Fluent English and Polish, a life-science degree, and 1 year in EC/CA submissions are required.