Location:

Poland

Job Description:

As a Clinical Research Associate, you will assume responsibilities encompassing various monitoring activities, contributing to clinical research across diverse therapeutic areas. Your role involves ensuring the adherence of clinical trials to the study protocol, ICH-GCP guidelines, and relevant regulations and standard operating procedures.

Key Responsibilities:

• Undertake the initiation, monitoring, and closure of clinical studies at research sites, aligning with pertinent regulations, ICH-GCP guidelines, and standard operating procedures.
• Prepare and execute submissions for regulatory and ethics approvals (pertaining to drugs, medical devices, and non-interventional studies) in accordance with applicable regulations, ICH-GCP guidelines, and the company's standard operating procedures (e.g., initial CA and EC submissions, amendments, notifications, progress and safety reports, and contract negotiations without direct oversight).
• Facilitate the contracting process between the Sponsor and Investigational sites.
• Conduct feasibility assessments and pre-study evaluations.
• Document activities in compliance with ICH-GCP and the company's standard operating procedures.
• Generate requested activity summaries and reports for the Manager.
• In addition to routine monitoring tasks, Senior CRAs will contribute to the training and guidance of junior CRA colleagues.
• All Senior CRAs will participate in the company's International CTL (Clinical Team Leader) training program and may have the opportunity to serve as junior CTLs under the supervision of a Senior Project Manager within 1-2 years.

Requirements:

• Possess a bachelor's degree in life sciences.
• Minimum of 1 year of experience in a CRA role.
• Proficiency in English at an advanced level.
• Strong IT skills.
• Valid driver's license.
• Effective communication, customer-centric approach, teamwork, time management, motivation for continuous learning and development.

What We Offer:

• Competitive and appealing compensation package.
• A dedicated and supportive team environment.
• Exposure to a multinational workplace.
• Regular team-building activities and company events.
• Flexible hybrid work.

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