Site Visit Report Reviewer
Core
Reviewing site qualification, initiation, monitoring, and termination visit reports to ensure quality and regulatory compliance in clinical trials.
Role type
Clinical Operations Specialist (Site Visit Report Reviewer)
Builds
Clinical trial monitoring reports and issue resolutions
Domain
Clinical Research / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Knowledge of ICH-GCP guidelines, clinical trial methodology, attention to detail, analytical skills, problem-solving, Microsoft Office proficiency
Preferred skills
Nursing qualification, biological science or pharmacy degree, experience in site management
Technologies
Microsoft Office
Responsibilities
Review site visit reports for quality and regulatory compliance, monitor Open Issues and Protocol Deviations, communicate periodic analyses of monitoring visits to project teams, follow up on Serious Adverse Events until closure
Seniority
Individual Contributor