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
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