Clinical Research Associate responsible for site monitoring and management to ensure protocol compliance and data quality. Conducts monitoring visits, manages recruitment, tracks regulatory submissions, and maintains study documentation according to GCP and ICH guidelines.
Responsibilities
Conduct site monitoring visits including initiation, ongoing monitoring, and close-out activities
Develop and track subject recruitment plans with sites to meet enrollment targets
Administer protocol training and maintain regular communication with assigned sites
Monitor study progress including regulatory approvals, enrollment, CRF completion, and data queries
Create and maintain monitoring visit reports, follow-up letters, and study documentation
Requirements
Bachelor's degree in scientific or healthcare discipline preferred
Minimum 1 year on-site clinical monitoring experience
Knowledge of GCP and ICH regulatory guidelines
Proficiency with Microsoft Office (Word, Excel, PowerPoint)
Strong written and verbal English communication skills
SummaryJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
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Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
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