RASSU Spec II

Job description

What You'll Do: - Assist/Advise project teams on all regulatory requirements for clinical studies - Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings - Review and adapt study specific documents according each country and site requirements - Perform IRB/EC (CA) and/ or other Regulatory Bodies submissions on behalf of sponsors and and/or sites as agreed with the Sponsor and in accordance with each country requirements - Receive and process study documentation from sites, check content and quality as well as completeness - Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review - Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements, perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements - Assist with and adapt Informed Consent Form (ICF) according to IRB/IEC requests on country or site level - Assist in prepar...