Senior Clinical Research Associate – FSP

🔥 4 minutes ago

🇮🇹 Italy – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Responsible for site management, site monitoring and close-out of assigned clinical trial investigator sites • Ensure patient safety and quality study execution • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan, applicable prevailing laws and Good Clinical Practices • Manage operational aspects of clinical trial activities at assigned investigator sites from site activation through database lock • Ensure relevant timelines and quality deliverables are met • Facilitate information flow between study team members, vendors and assigned investigator sites • Monitor site-level AEs and SAEs • Collaborate with the Drug Safety Unit and follow up with investigator sites to resolve required SAE report information • Serve as a point of contact for audits • Drive Audit Observation CAPA development and checks when applicable

🎯 Requirements

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Minimum 5 years relevant experience in clinical research site monitoring • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases • Candidates without notice will be reviewed as priority due to the immediate start

🏖️ Benefits

• Fixed-term contract until April 2027, with potential to extend/be made permanent thereafter