OverviewSenior CRA role with Parexel FSP supporting a large EU sponsor on a fixed-term contract through Apr ****.
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.
ResponsabilitàOversee 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
Requisiti fondamentaliBachelor'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

📌 Immediate Start - Senior Clinical Research Associate - Fsp - Until April 2027 (Terni)
🏢 Parexel
📍 Terni