International conference on harmonization (ich) guidelines
Site monitoring visit execution
The role involves performing site monitoring visits including selection, initiation, monitoring, and close-out in accordance with GCP and ICH guidelines
Job Summary
The role involves performing site monitoring visits including selection, initiation, monitoring, and close-out in accordance with GCP and ICH guidelines.
Candidates will work with sites to adapt and track subject recruitment plans while ensuring the integrity of study data and practices.
The position requires managing regulatory submissions, enrollment progress, and maintaining the Investigator's Site File according to local requirements.
Matching Summary
The role involves performing site monitoring visits including selection, initiation, monitoring, and close-out in accordance with GCP and ICH guidelines.
Skills & Requirements
Must-have
Good Clinical Practice (GCP) knowledge
International Conference on Harmonization (ICH) guidelines
Site monitoring visit execution
Subject recruitment plan management
Trial Master File maintenance
Nice-to-have
Strong problem-solving skills
Effective time management abilities
Collaborative team relationship building
Key Requirements
Bachelor's Degree in scientific discipline or health care
At least 1 year of on-site monitoring experience
Proficiency in Microsoft Word, Excel, and PowerPoint