The role involves performing site monitoring visits including selection, initiation, monitoring, and close-out to ensure protocol compliance
Job Summary
The role involves performing site monitoring visits including selection, initiation, monitoring, and close-out to ensure protocol compliance.
Candidates must manage study progress by tracking regulatory submissions, enrollment, and data query resolution while maintaining accurate documentation.
The position requires evaluating site practices for quality and integrity, escalating issues as appropriate, and ensuring Investigator's Site File maintenance.
Matching Summary
The role involves performing site monitoring visits including selection, initiation, monitoring, and close-out to ensure protocol compliance.
Skills & Requirements
Must-have
Good Clinical Practice (GCP) knowledge
4 years on-site monitoring experience
Subject recruitment plan management
Trial Master File (TMF) maintenance
Protocol adherence evaluation
Nice-to-have
Mentoring new or junior CRAs
Site financial management skills
Effective time management skills
Strong problem-solving abilities
Collaborative team working relationships
Key Requirements
Bachelor's Degree in scientific discipline or health care
At least 4 years of on-site monitoring experience
Proficiency in Microsoft Word, Excel, and PowerPoint