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Senior CRA role with Parexel FSP supporting a large EU sponsor on a fixed-term contract through Apr 2027. You will oversee site management, monitoring, and study close-out to ensure patient safety and high‑quality trial execution. The role involves cross‑functional collaboration, handling AEs/SAEs, and driving audit CAPA processes. You’ll work remotely from Italy, focusing on oncology or related therapeutic areas, contributing to meaningful clinical development. This is a mission‑driven opportunity to impact patient outcomes through rigorous monitoring and compliance.
Responsabilità- Oversee site management, monitoring, and close-out for assigned trials to ensure safety and quality
- Ensure protocol adherence, regulatory compliance (ICH/GCP, FDA, local regs), and timely deliverables from activation to database lock
- Coordinate information flow between study team, vendors, and investigator sites
- Monitor AEs/SAEs and liaise with Drug Safety Unit to resolve required information
- Act as audit contact and drive CAPA development and follow-up
- Bachelor’s degree in life sciences or professional degree in life sciences (nursing, pharmacy, medical background)
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local regulations
- Monitoring experience: minimum 5 years in clinical research site monitoring (oncology preferred)
- Strong communication and collaboration
- Empathy and patient-centric mindset
- Problem-solving and attention to detail
- ICH-GCP familiarity
- FDA and local regulatory knowledge
- Site monitoring and trial conduct
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