iCRA II

When our values align, there's no limit to what we can achieve.
 

An initiation Clinical Research Associate (iCRA) specializing in Pre SIV and Activation tasks will be assigned & accountable for managing and driving the strategy for the startup, Pre SIV and Activation tasks of the study. The iCRA also supports submission and approval process for the protocol amendments if applicable.

In Japan for studies that are using Parexel SOPs, prior to SIV the iCRA will be responsible for preparing the initial site related IRB application and associated documents required prior to SIV as delegated by CRA and reviewing and approving all essential documents (SRP/Site Greenlight, ICF, etc.). Post SIV the iCRA would review / approve the documents as determined by Parexel SOPs (e.g., SRP/Site Greenlight & ICF). For studies that use client SOPs, the necessity for the iCRA role will depend on the contracted tasks/procedures; if the iCRA role is not required the CRA will...