Clinical Research Associate, Sponsor Dedicated at IQVIA Lake, WV
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Clinical Research Associate, Sponsor Dedicated Job at IQVIA, Lake, WV
Clinical Research Associate role supporting sponsor-dedicated monitoring activities across multiple U.S. sites. Responsible for site management, protocol compliance, data integrity oversight, and regulatory documentation in accordance with GCP and ICH guidelines.
Conduct site monitoring visits including initiation, ongoing monitoring, and close-out activities per protocol and GCP
Develop and track subject recruitment plans with sites to meet enrollment targets
Deliver protocol training and maintain regular site communication to manage expectations and resolve issues
Monitor study data quality, protocol adherence, and regulatory compliance; escalate concerns as needed
Track study progress including regulatory submissions, enrollment, CRF completion, and data queries
Bachelor's degree in scientific or healthcare discipline preferred
At least 2 years independent on-site monitoring experience as CRA
Strong knowledge of GCP and ICH regulatory requirements
Proficiency with EDC, CTMS, eTMF, IVRS/IWRS systems
Advanced Microsoft Office skills (Word, Excel, PowerPoint)
Excellent written and verbal English communication abilities
Strong organizational, problem-solving, and time management skills
Work at office
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