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.

Start-up (from Site Identification Through Site Activation)

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.

• Build relationships with investigators and site staff.
• Support on request country specific feasibility and/or site pre-qualification and qualification activities, which may include:
  • Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA) and any amendments.
  • May conduct remote Qualification Visits (QVs).
• Liaison with stakeholders to understand Clinical Site Agreeme...