RASSU Spec II (European lead role)

Responsibilities

• 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/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, clarifications, 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 revie...