Senior Clinical Research Associate (Lead CRA)

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.
+ To prepare, lead, and follow up on re...