As a Clinical Research Associate I, you will ensure clinical trials are conducted according to approved protocols, ICH-GCP guidelines, and applicable regulations to guarantee subject safety and data reliability
Job Summary
As a Clinical Research Associate I, you will ensure clinical trials are conducted according to approved protocols, ICH-GCP guidelines, and applicable regulations to guarantee subject safety and data reliability.
You will perform remote or on-site visits to monitor investigator sites, apply risk-based monitoring, document observations, and escalate issues to clinical management for resolution.
The role involves frequent travel (60-80% or more), maintaining audit readiness, facilitating communication between sites and project teams, and contributing to process improvements.
Matching Summary
As a Clinical Research Associate I, you will ensure clinical trials are conducted according to approved protocols, ICH-GCP guidelines, and applicable regulations to guarantee subject safety and data reliability.
Skills & Requirements
Must-have
Risk-based monitoring approach
Protocol and regulatory compliance assessment
Clinical trial documentation management
Root cause analysis and problem solving
On-site and remote clinical monitoring
Good communication with medical personnel
Frequent travel to clinical sites
Nice-to-have
Critical thinking skills
Team collaboration and independent work
Process improvement initiatives
Good organizational and time management skills
Customer focus and listening skills
Ability to adapt to various scenarios
Proficiency with Microsoft Office and clinical software
Key Requirements
Bachelor's degree in life sciences or Registered Nursing certification
Approximately 2 years clinical monitoring experience