Parexel Is Hiring A Senior Cra

Join Parexel FSP as a seasoned Senior Clinical Research Associate (CRA) and be part of a dynamic team monitoring 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 oversee site management, monitoring, and close-out activities for key clinical trials with one of our major sponsors in the EU. This role involves travel across Italy and Spain, requiring excellent coordination and scientific expertise.

📝 Key Responsibilities

• Ensure Compliance: Conduct clinical trials per the Study Monitoring Plan, applicable laws, and Good Clinical Practices (GCP).
• Operational Management: Manage trial activities at investigator sites from activation to database lock, meeting timelines and quality standards.
• Team Collaboration: Facilitate communication among study team members, vendors, and investigators to ensure seamless information flow.
• Safety Monitoring: Monitor Adverse Events (AEs) and Serious Adverse Events (SAEs), collaborating with the Drug Safety Team to resolve reports efficiently.
• Audit Readiness: Act as a point of contact for audits and oversee CAPA development and follow-up on audit observations.

🤝 About Parexel

Parexel supports clinical research across various therapeutic areas with longstanding partnerships worldwide. We have contributed to the development of many top 50 best-selling drugs and support niche therapies vital to patient care.

As part of our team, you will be an influential contributor to advancing healthcare solutions globally. 🌟

🎯 What We Are Looking For

We value professionals committed to putting patient well-being first—working with heart.

📝 Role-Specific Requirements

• Bachelor’s degree in life sciences or a related professional degree (e.g., nursing, pharmacy, medical background) or equivalent.
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations.
• Minimum of 3.5 years of relevant experience in clinical site monitoring, preferably in Oncology.
• Preferred experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.
• Monitoring experience across both Italy and Spain.
• Language skills in English, Italian, and Spanish are essential.

#LI-REMOTE

📝 EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. 🌍