Clinical Research Associate

2 giorni fa

Siena, Tuscany, Italia PAREXEL Tempo pieno
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