Responsibilities
Si sus habilidades, experiencia y cualificaciones coinciden con las de esta descripción del puesto, no demore su solicitud.
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 Managersof 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 documenta...