Senior Clinical Research Associate (Lead CRA)
IQVIAJob Description
The Lead CRAs will be assigned as CRA to one study site as a minimum to verify an adequate understanding of sponsor requirements, procedures, and systems. Thus, requiring the CRA to have more than 4 years of onsite monitoring experience.
The main responsibilities of the Lead CRA are:
To oversee the overall study monitoring plan compliance for the studies and countries assigned.
To serve as the primary point of contact for IQVIA CRAs and sponsor LSADs for any study monitoring-related questions or concerns.
To provide oversight of site monitoring data management activities (entails pulling data management reports and leading the follow-up on missing pages, outstanding queries, etc.).
To review Monitoring Visit Reports and advise CRAs on any study-related questions. Initially, 100% MVR review is expected, moving in the future to a risk-based approach after consultation and agreement with sponsor Project Manager.
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