Key Accountabilities Clinical Trial Site Activation Initiate and coordinate activities and essential documents management during start up towards the compilation of a high quality Investigator Initiation Package (IIP) leading to approval for site initiation Provide support to resolve issues or concerns and timely escalation of site issues where applicable Prepare validate and submit regulatory documents such as completed IIP Institutional Review Board (IRB) approval forms FDA 1572/Attestation Form for internal regulatory approval within required timelines Manage and coordinate with other supporting roles to ensure timely site activation and operational activities Support the compilation of the Central Investigator Review Board package and submissions to approval of the study (where applicable) and other committees as per country requirements Coordinate the timely communication … Sign In to View