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Clinical Study Associate I
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- Coordinate the day-to-day execution of clinical trials, with a focus on site start-up, patient enrollment, monitoring, and data flow metrics from clinical sites, clinical research organizations (CROs), and central labs.
- Utilize knowledge of clinical data research methods, such as Trial Master File ("TMF") to track critical clinical research documents and ensure proper recordkeeping and filing according to federal and global regulatory standards.
- Position Requirements: Bachelor's degree in Biology, Neuroscience, Clinical Trials Management, or a closely related field (or foreign equivalent degree), plus 2 years of experience in pediatric rare disease clinical trial operations in a pharmaceutical, CRO, or clinical research site (e.g., academic hospital) environment.
- 2 years of applying working knowledge in ICH/GCP, regulatory requirements, and Standard Operating Procedures to coordination of clinical trials and trial data.
- 2 years of experience with clinical trial and clinical data systems (EDC, electronic medical records), EMR, CTMS.
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