The role involves performing selection, initiation, monitoring, and close-out visits to ensure sites conduct studies according to the protocol and regulations
Job Summary
The role involves performing selection, initiation, monitoring, and close-out visits to ensure sites conduct studies according to the protocol and regulations.
Candidates must work with sites to drive subject recruitment plans and manage ongoing project expectations through regular communication.
The position requires maintaining the Investigator's Site File in accordance with GCP and local regulatory requirements while generating necessary documentation.
Matching Summary
The role involves performing selection, initiation, monitoring, and close-out visits to ensure sites conduct studies according to the protocol and regulations.
Skills & Requirements
Must-have
Good Clinical Practice (GCP) knowledge
Site monitoring visit execution
Subject recruitment plan management
Trial Master File maintenance
Regulatory submission tracking
Nice-to-have
Strong problem-solving skills
Effective time management abilities
Collaborative team working style
Financial management experience
Adaptability to project needs
Key Requirements
Bachelor's Degree in scientific discipline or healthcare
At least 2 years of on-site monitoring experience
Proficiency in Microsoft Word, Excel, and PowerPoint
Knowledge of ICH guidelines and applicable regulations