About this role

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

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 of 5 years relevant experience in clinical research site monitoring (preferably in Oncology)

Senior Clinical Research Associate – FSP

Key skills