CRA / Clinical Research Associate

Pharmaxi LLC.; Warszawa; On-site; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Career development opportunities

International projects exposure

Supportive clinical research team

Job summary

Pharmaxi LLC. is seeking a Clinical Research Associate to support the delivery of clinical trials through site monitoring, documentation control and collaboration with project teams. You will ensure GCP compliance and data quality while working with international sites.

The role requires independent work, attention to detail, and strong communication skills. On-site Warsaw position offering opportunities to develop in monitoring and trial quality management.

Qualifications

• Experience in clinical trial monitoring or in clinical research.
• Knowledge of GCP principles and regulatory requirements for clinical trials.
• Good organizational skills and ability to manage documentation.
• Communication skills and ability to cooperate with investigational sites.
• Knowledge of English sufficient to work with project documentation.

Responsibilities

• Monitor clinical trials in accordance with the protocol and GCP requirements.
• Cooperate with investigational sites, investigators and site personnel.
• Verify clinical trial documentation and data completeness.
• Prepare monitoring visit reports.
• Identify risks, deviations and operational issues.
• Collaborate with Project Manager, CTA, regulatory affairs and data management.
• Support site preparation for study start-up, conduct and close-out.

Skills

Site Monitoring

GCP Knowledge

Documentation

Communication

English Proficiency

Tools

EDC

eTMF

Job description

Join Pharmaxi as a Clinical Research Associate and support the delivery of clinical trials through site monitoring, documentation control and cooperation with project teams. This position is intended for people who understand the clinical trial process well, can work independently and pay attention to data quality and compliance of activities with GCP requirements.

Scope of responsibilities

• monitoring clinical trials in accordance with the protocol, procedures and GCP requirements,
• cooperation with investigational sites, investigators and site personnel,
• verification of clinical trial documentation and data completeness,
• preparation of monitoring visit reports,
• identification of risks, deviations and operational issues,
• cooperation with the Project Manager, CTA, regulatory affairs and data management departments,
• supporting site preparation for study start-up, conduct and close-out.

Requirements

• experience in clinical trial monitoring or work in the area of clinical research,
• knowledge of GCP principles and basic regulatory requirements for clinical trials,
• good work organisation and ability to manage documentation,
• communication skills and ability to cooperate with investigational sites,
• knowledge of English sufficient to work with project documentation,
• accuracy, responsibility and independence in task delivery.

Nice to have

• experience working in a CRO, pharmaceutical company or international projects,
• knowledge of EDC, eTMF systems or other tools used in clinical trials,
• experience in studies involving medicinal products, medical devices or IVD.

What we offer

• participation in clinical trial projects,
• cooperation with an experienced clinical research team,
• opportunity to develop in monitoring and trial quality management,
• clear communication and subject-matter support in carrying out tasks,
• work on national and international projects.