Sr. CRA1 in Thana, भारत

Senior Clinical Research Associate responsible for site monitoring and management across clinical trials in India. Ensures sites comply with protocol requirements, regulatory guidelines, and sponsor expectations while managing recruitment, data quality, and documentation.

Responsibilities

• Conduct site monitoring visits including initiation, ongoing monitoring, and close-out activities
• Develop and track subject recruitment plans aligned with study timelines and project needs
• Administer protocol training and maintain regular communication with assigned sites
• Evaluate site compliance with protocol, regulations, and GCP standards; escalate quality issues
• Manage study progress including regulatory tracking, enrollment, CRF completion, and data queries

Requirements

• Bachelor's degree in scientific or healthcare discipline
• Minimum 2 years of on-site clinical trial monitoring experience
• Knowledge of GCP and ICH guidelines and regulatory requirements
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Strong written and verbal English communication skills
• Organizational, problem-solving, and time management abilities