Poland Clinical Research Associate II/III — Impact & Growth

Optimapharm; Kraków; Hybrid; PLN 110,000 - 160,000; Full time

Benefits offered by this job

Performance bonus

Flexible hours

Car allowance

Work from home allowance

Health insurance

Training program

Well-being initiatives

Employee engagement

Job summary

Optimapharm in Poland is seeking a Clinical Research Associate (CRA II-III) to join our growing global team. You will perform routine site visits, monitor trials, and manage site relationships to ensure compliance and quality data.

Ideal candidates have a university degree in life sciences, at least 2 years of independent monitoring experience, strong knowledge of ICH GCP, and fluent English and Polish. This role offers professional growth and integration into international projects.

Qualifications

• University degree in medical or life sciences is required.
• At least 2 years of independent clinical trial monitoring experience.
• High level of knowledge of ICH GCP guidelines and regulatory requirements.
• Fluent in Polish and English, both written and verbal.
• Computer proficiency is mandatory.

Responsibilities

• Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits.
• Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements.
• Independently perform CRF review; query generation and resolution against data review guidelines or data management systems.
• Identify and escalate potential risks and retraining opportunities for site personnel.
• Prepare CAPA plans for issues identified during monitoring activities and follow through until resolution.
• Prepare documents required for EC submissions and notifications, translate study-related documents where applicable, and other tasks as instructed by the supervisor.
• Independently negotiate study budgets with investigators/institutions and assist with site contracts as applicable.
• Administration of site payments in accordance with project instructions.

Skills

ICH GCP knowledge

Regulatory awareness

English fluency

Polish fluency

Independent monitoring

Education

University degree in medical or life sciences

Tools

Data management systems

Job description

Optimapharm in Poland is seeking a Clinical Research Associate (CRA II-III) to join our growing global team. You will perform routine site visits, monitor trials, and manage site relationships to ensure compliance and quality data.

Ideal candidates have a university degree in life sciences, at least 2 years of independent monitoring experience, strong knowledge of ICH GCP, and fluent English and Polish. This role offers professional growth and integration into international projects.