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

📌 Principal RASSU Specialist (España)
🏢 Cti Clinical Trial And Consulting Services
📍 España