Regulatory Affairs Study Start Up Specialist II

Job description

Please do not apply if you are not fully eligible to work in Australia. CTI doesn't offer any Sponsorship. About CTI: CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com 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/or sites as agreed with the Sponsor and in accordance with each country requirements - Receive and process study docum...