Parexel Is Hiring A Senior Cra

Join Parexel FSP as a Senior Clinical Research Associate (CRA) and be part of a dynamic team supporting clinical trials across Italy and Spain, ensuring patient safety and high-quality study execution. 🌍

About the Role

We are seeking an experienced Senior CRA to monitor clinical sites in Italy and Spain for a key sponsor. In this position, you'll manage site activities, monitor trial progress, and ensure compliance with regulatory standards to safeguard patient well-being.

Key Responsibilities 📝

• Ensure proper conduct of clinical trials in line with the Study Monitoring Plan, laws, and Good Clinical Practices (GCP).
• Manage operational aspects of clinical trial activities from site activation to database lock, meeting timelines and quality standards.
• Facilitate communication between the study team, vendors, and investigator sites to promote information flow and collaboration.
• Monitor site-level adverse events (AEs) and serious adverse events (SAEs), collaborating with the Drug Safety Unit to resolve issues promptly.
• Coordinate audits by serving as the point of contact, and oversee the development and closure of audit observations and Corrective and Preventive Actions (CAPA).

Who is Parexel? 🤝

Parexel supports a broad spectrum of clinical research across various therapeutic areas, fostering long-term partnerships with a diverse client base. We have contributed to the development of many top-selling drugs and innovative therapies that improve patient lives worldwide.

As a part of our team, you'll be an influential member contributing to meaningful healthcare advancements.

What We Are Looking For 🌟

At Parexel, we seek dedicated professionals committed to putting patient safety first — working with heart and determination.

Role-Specific Requirements ✅

• Bachelor's degree in life sciences or a related professional qualification (e.g., nursing, pharmacy, medicine).
• Extensive knowledge of clinical trial procedures, ICH/GCP, FDA, and local regulations.
• Minimum of 3.5 years relevant experience in site monitoring (preferably in Oncology).
• Therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases is preferred.
• Experience monitoring trials across both Italy and Spain is required.
• Proficiency in English, Italian, and Spanish languages.

#LI-REMOTE

Equal Opportunity Employment 🌍

Parexel is an equal opportunity employer. Qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.