Syneos health
Clinical Research Associate
Overview
Performs site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice and protocol compliance.
About Syneos health
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Requirements & Eligibility
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines
Key Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice and protocol compliance.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site.
- Conducts Source Document Review of appropriate site source documents and medical records.
- Verifies required clinical data entered in the case report form is accurate and complete.
- Routinely reviews the Investigator Site File for accuracy, timeliness and completeness.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
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