As a Clinical Research Associate at IQVIA, you will monitor clinical sites and ensure compliance with GCP and ICH guidelines. Responsible for site management and recruitment planning in Poland.
About the role
- Clinical Research Associate specializing in oncology clinical trials at Excelya. Conducting site monitoring and ensuring compliance with clinical protocols and regulatory guidelines.
Responsibilities
- **Main Responsibilities:**
- Conduct site monitoring, and close-out visits for oncology clinical trials.
- Ensure compliance with protocols, ICH-GCP guidelines, and regulatory requirements throughout the study lifecycle.
- Maintain effective communication with investigators and site staff, providing ongoing support and guidance.
- Review study-related documentation and assist in the resolution of any issues related to data collection and study procedures.
- Prepare for and participate in audits and inspections, ensuring the sites are inspection-ready at all times.
- Track and report any deviations, adverse events, and other issues to the relevant stakeholders.
- Assist in the development and updates of study protocols and informed consent forms specifically for oncology studies.
Requirements
- **About You:**
- **Experience:** Minimum of 2 years experience as a Clinical Research Associate, with a strong background in oncology clinical trials.
- **Skills:** Proficient understanding of clinical trial methodologies and regulatory requirements. Excellent communication, organizational, and problem-solving skills.
- **Education:** Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
- **Languages:** Fluent in English and French, with the ability to communicate effectively in both languages.
Benefits
- **Why Join Us?**
- At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
- Here’s what makes us unique.
- We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s **leading mid-size CRO **with the **best employee experience**. Our **one-stop provider service model **offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
- **Excelling with care** means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
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