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Clinical Data Associate - I
Ref No.: 18-11803
Location: Foster City, California
Works collaboratively with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians and others Clinical, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for routine to basic clinical data acquisition, quality checking and reporting.Ensures completeness, correctness and consistency of clinical data and data structure. Assists in the implementation of clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery. Assists in the preparation of CRF/eCRF data collection through the regulatory approval process. Assists field clinical staff in collecting data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves basic queries.Utilizes reports to track study progress and ensure timeliness and quality expectations are met.Should have basic knowledge of FDA regulations and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems. Must be able to effectively communicate and possess good problem solving as well as people/project leadership skills.