Clinical Research Associate - Sponsor Dedicated at IQVIA Overland Park, KS

Clinical Research Associate - Sponsor Dedicated Job at IQVIA, Overland Park, KS
Clinical Research Associate responsible for monitoring clinical trial sites and ensuring protocol compliance, regulatory adherence, and data quality. The role involves site visits, recruitment oversight, training, documentation management, and cross-functional collaboration with study teams.
Conduct site monitoring visits including selection, initiation, ongoing monitoring, and close-out activities per protocol and regulations
Develop and track subject recruitment plans with sites to support enrollment goals
Train assigned sites on protocol requirements and maintain regular communication regarding expectations and issues
Assess study site practices for protocol adherence and regulatory compliance; escalate quality concerns
Generate visit reports, follow-up documentation, and maintain Trial Master Files and Investigator's Site Files per GCP/ICH standards

Bachelor's degree in scientific or healthcare discipline, or equivalent education and experience
Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Prior clinical research monitoring experience or completion of CRA training program
Proficiency with Microsoft Office (Word, Excel, PowerPoint) and laptop/mobile devices
Strong written and verbal English communication skills
Organizational, problem-solving, and time management abilities

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