The Company:
Our client is a Top-Tier Global Clinical Research Organization (CRO) and a premier leader in healthcare intelligence. Operating across 40+ countries, they provide end-to-end drug development solutions for the world's leading biopharmaceutical companies. This role sits within their specialized high-growth division, focusing on cutting-edge clinical trials that are shaping the future of medicine.
The Role: CRA I/CRA II
Key Responsibilities
- Site Management: Conduct the full range of site visits, including qualification, initiation, routine monitoring, and close-out.
- Compliance & Safety: Ensure strict protocol adherence and data integrity while upholding patient safety in accordance with ICH-GCP guidelines and local regulations.
- Stakeholder Collaboration: Build and maintain strong relationships with investigators and site staff to facilitate smooth study conduct and resolve site-level issues.
- Data Quality: Perform rigorous data reviews and resolution of queries to maintain the highest quality of clinical data for study reporting.
- Documentation: Contribute to the preparation and review of essential study documents, including clinical study reports and site monitoring logs.
Your Profile:
- Education: Bachelor's degree in a scientific, healthcare, or related life sciences field.
- Experience: A minimum of 3 years of hands-on experience as a Clinical Research Associate with a strong background in On-Site Monitoring. (Global Studies not local)
- Therapeutic Expertise: Mandatory experience in Oncology or Immunology therapeutic areas.
- Regulatory Knowledge: In-depth understanding of clinical trial processes, global regulations, and ICH-GCP guidelines.
- Technical Skills: Proficient in using Clinical Trial Management Systems (CTMS) and electronic Data Capture (eDC) platforms.
- Soft Skills: Exceptional organizational and communication skills, with a sharp eye for detail and the ability to thrive in a fast-paced environment.
