Parexel Is Hiring A Senior Cra

Join Parexel FSP as an experienced Senior Clinical Research Associate (CRA) and play a vital role in monitoring clinical sites across Italy and Spain for a key sponsor in the EU. This position emphasizes site management, study monitoring, and ensuring patient safety and quality.

🚀 About the Role

As a Senior CRA, you will be responsible for overseeing the conduct of clinical trials at investigator sites, from activation through close-out, ensuring compliance with protocols, GCP, and regulatory requirements. You will collaborate closely with study teams, vendors, and site staff to support successful study execution.

Key Responsibilities

• Clinical Trial Conduct: Ensure trials are conducted in line with the Study Monitoring Plan, laws, and GCP standards.
• Site Management: Manage operational aspects at investigator sites, from activation to database lock, meeting timelines and quality benchmarks.
• Communication & Coordination: Interface with study teams, vendors, and sites to facilitate smooth information flow.
• Safety Monitoring: Monitor site-level AEs and SAEs, collaborating with the Drug Safety Unit to resolve safety reports efficiently.
• Audit Readiness: Act as the point of contact during audits and support CAPA development following observations.

🌍 Who We Are

Parexel supports clinical research across various therapeutic areas, working with both leading drugs and niche developments that significantly impact patient health. We foster a collaborative environment where team members are influential contributors to groundbreaking research.

🎯 What We Seek in You

We value professionals who are committed to putting patient well-being first, working with heart and determination. Specifically, for this role, we look for:

• Educational Background: Bachelor's degree in life sciences or related professional healthcare field (e.g., nursing, pharmacy, medical).
• Regulatory Knowledge: Deep understanding of clinical trial methodologies, ICH/GCP, FDA, and local regulations.
• Monitoring Experience: At least 3.5 years of site monitoring experience, preferably in Oncology.
• Therapeutic Experience: Oncology, Vaccines, Internal Medicine, or Infectious Diseases.
• Cross-country Monitoring: Experience monitoring in both Italy and Spain.
• Language Skills: Fluency in English, Italian, and Spanish.

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🛡️ EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected classifications.