Please submit your application in English What You'll Do: Support of Regulatory Affairs Study Start-Up (RASSU) department: 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 sites requirements Perform / oversee IRB/IEC/ 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 and /or 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 Adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level and / or assessing accuracy Preparation and/or quality check and filing of site adapted ICF according to local requirements Prepare or/and QC Clinical Trial Application forms (e.g. CTA, XML), where applicable Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs Respond to Deficiency Letters from IRB/IEC/CA and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements Compiling and/or assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist) Provide Pro

📌 Principal rassu specialist (Cantabria)
🏢 Cti Clinical Trial And Consulting Services
📍 Cantabria