Senior Clinical Research Associate – Sponsor Dedicated – Oncology Experience Needed

Overview

In this Senior CRA role, you will lead site management, monitoring, and close-out for investigator sites in alignment with the Study Monitoring Plan and GCP. You’ll drive trial activities from activation to database lock, ensuring timelines and quality deliverables. You will coordinate with study teams, vendors, and sites, and manage safety reporting with the Drug Safety Unit. You’ll also support audit processes and CAPA development. This is a senior, patient-focused role within Parexel’s FSP model, offering exposure to diverse sponsors and therapeutic areas.

Responsibilities

• Manage site activation, monitoring, and close-out to ensure safety and quality
• Ensure trial conduct per Monitoring Plan and GCP/ICH/FDA regulations
• Coordinate information flow among study team, vendors, and investigator sites
• Monitor AEs/SAEs and liaise with Drug Safety Unit for resolution
• Serve as audit contact and drive CAPA development and checks
• Support Audit observations and continuous quality improvements

Key requirements

• Bachelor in Life Sciences or equivalent
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local regulations
• Monitoring experience of at least 3.5 years in clinical research site monitoring (preferably Oncology)
• Preferred experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases

• Strong collaboration and communication with cross-functional teams
• Problem-solving mindset with attention to safety and quality
• Patient-centric approach and empathy
• ICH-GCP knowledge
• FDA and local regulations awareness
• Site monitoring and trial conduct

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