CRA 1/2 in Thana, भारत

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
• Organizational and problem-solving abilities