[Hiring] Senior Clinical Research Associate @Parexel

Role Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

This role is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution.

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met.
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.
• Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution.
• Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable.

Qualifications

• 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 relevant experience in clinical research site monitoring (preferably in Oncology).
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases.

Requirements

• Determination and courage to always put patient well-being first.