Clinical Research Associate / Senior - FSP - Remote

Overview

In this role, you will lead site management and monitoring for assigned trials to ensure patient safety and high-quality execution. You will work with cross-functional teams to keep study activities on track from activation to database lock. You will monitor AEs/SAEs and support Drug Safety, audits, and CAPA implementation. This is a remote, Italy-based position within Parexel FSP, offering the chance to contribute to meaningful clinical development across therapeutic areas.

Responsabilità

• Manage site-level activities from activation to database lock to meet timelines and quality expectations
• Oversee site monitoring and close-out to ensure protocol and regulatory compliance
• Coordinate information flow between study team, vendors, and investigator sites
• Monitor AEs/SAEs and collaborate with Drug Safety to resolve required information
• Serve as audit contact and drive CAPA development and checks as needed

Requisiti fondamentali

• Bachelor's degree in life sciences or equivalent professional life sciences qualification
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local regulations
• Minimum 3.5 years of site monitoring experience in clinical research ( Oncology preferred)
• Oncology, Vaccines, Internal Medicine or Infectious Diseases experience preferred
• strong communication and collaboration
• patient-centered mindset
• problem-solving and proactive follow-up
• clinical trial monitoring
• ICH/GCP
• FDA and local regulations