Senior Clinical Research Associate

Overview

In this Senior CRA role, you will oversee site management, monitoring, and close-out for assigned investigative sites to safeguard patient safety and ensure high-quality study execution. You’ll manage operational activities from site activation to database lock and coordinate with cross-functional teams to maintain timelines. You will monitor AEs/SAEs and support audit processes, driving CAPA where needed. Join Parexel FSP to contribute to clinical development that benefits patients while working with a collaborative sponsor team.

Responsibilities

• Manage site activation, monitoring, and close-out for investigator sites
• Ensure trial conduct adheres to the Study Monitoring Plan, ICH/GCP, FDA and local regulations
• Coordinate with study team, vendors, and sites to ensure timely, quality deliverables
• Monitor site-level AEs/SAEs and liaise with Drug Safety Unit for resolution
• Act as point of contact for audits and drive CAPA development and checks

Key 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
• Monitoring experience: minimum 3.5 years in clinical research site monitoring (preferably Oncology)
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases

• patient-centric mindset
• collaborative communication
• proactive information flow and coordination
• clinical trial methodologies
• ICH/GCP and FDA regulations
• site monitoring and CAPA processes

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