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PAREXEL

Brescia / Global

Clinical Research Associate / Senior - FSP - Remote

  • Remote

Job Description

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

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