The Senior Clinical Research Associate ​is responsible for developing comprehensive study plans/protocols, ensuring adherence to ISO/FDA regulatory requirements, Good Clinical Practice (GCP) guidelines, and study objectives to ensure robust data integrity and study execution.
**Your role:**
+ Provides support to the Clinical Study Manager by supervising study sites and activities to ensure strict adherence to clinical study protocols, regulatory standards (ISO, GCP, FDA), and Philips procedures; this includes conducting site assessments, on-site and remote monitoring, and close-out visits, as well as resolving any queries, issues, and discrepancies related to study conduct, data collection/integrity, and regulatory compliance.
+ Ensures efficient organization and accessibility of study-specific materials/documentation, including protocols, informed consent forms, and study manuals, ensuring compliance with regulatory requirements and GCP guidelines.
+ Enhances study procedu...