• To perform Centralized activities in cRSU and be the interface to the RSU Specialist at European level.
• Review of Documents for the completeness and accuracy according to the study requirements.
• Compilation of EDP pack and IP release activities for the sites involved in the study
• Procuring essential documents from sites and filing in eTMF in a timely manner and updating CTMS- tracking and linking the submission documents.
• Filing online submission form as a part of submission activity and linking these documents.
• Perform CTA Amendment activities, preparation of budget negotiations as per study and country requirements and incorporating the budget with approval of Site and the Sponsor.
. Supporting Project Management team in review of RSU specific eTMF review in close-out stage of study.
. Preparing site specific logs and forms and cascading them to CRA before Site Initiation Visit.
. Tracking of correspondence documents(questions and response) from Ethics Committee or Regulatory body.
. Supporting and coordination with Project Management team for eTMF review at the close-out phase.