Parexel Is Hiring A Senior Cra

Join Parexel FSP as an experienced Senior Clinical Research Associate (CRA) to oversee clinical trials across Italy and Spain, ensuring patient safety and high-quality study execution. 🌍

About the Role

As a Senior CRA, you will be responsible for site management, monitoring, and trial close-out activities at investigator sites in Italy and Spain. Your role is vital to maintaining compliance with regulatory standards and ensuring the integrity of clinical data.

Key Responsibilities 🔑

• Ensure proper conduct of trials: Adhere to Study Monitoring Plan, Good Clinical Practices, and applicable laws.
• Operational management: Oversee trial activities from site activation to database lock, meeting timelines and quality standards.
• Communication: Facilitate information exchange among study team members, vendors, and investigator sites.
• Safety Monitoring: Monitor site-level adverse events (AEs) and serious adverse events (SAEs), collaborating with the Drug Safety Unit to resolve reports.
• Audit Support: Act as the primary contact for audits and lead CAPA development and follow-up when necessary.

Who is Parexel?

At Parexel, we support clinical trials across a broad range of therapeutic areas and maintain long-standing partnerships with clients worldwide. Our portfolio includes trials for many of today’s top 50 best-selling drugs, as well as niche developments vital to patient well-being. 🌟

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

What We’re Looking For

We seek dedicated professionals who prioritize patient well-being and are courageous in their work — working with heart. ❤️

Role-Specific Requirements 📝

• Bachelor’s degree in life sciences or equivalent (e.g., nursing, pharmacy, medical background).
• Extensive knowledge of clinical trial methodologies, ICH/GCP guidelines, FDA regulations, and local country laws.
• Monitoring experience: Minimum 3.5 years of clinical research site monitoring, preferably in Oncology.
• Preferred therapeutic background in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.
• Experience monitoring trials across both Italy and Spain.
• Proficiency in English, Italian, and Spanish languages.

Additional Details

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EEO Statement

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