Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements
Job Summary
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
Act as a mentor for clinical staff including conducting co-monitoring and training visits.
Matching Summary
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements.
Skills & Requirements
Must-have
Site monitoring visits
Subject recruitment plan
Protocol and study training
Quality and integrity evaluation
Trial Master File (TMF)
Investigator's Site File (ISF)
Nice-to-have
Mentoring clinical staff
Collaborate with study team
Financial management skills
Key Requirements
4-5 years on-site monitoring experience
1 year as a SR CRA
Bachelor's Degree in scientific discipline or health care
Good command of English language
Proficiency in Microsoft Word, Excel and PowerPoint