Regulatory Affairs Study Start Up Specialist (level dependent on experience)

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 Job Purpose/ Summary: Manage essential regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB)Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally.

Interact with, assist and advise study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment and processing of essential regulatory documentation and to provide ongoing status reports about the documentation.

Maintain essential regulatory documentation for multiple studies and perform review, reconciliation, close-out and archiving activities of study or project documentation according to CTI or Sponsor SOPs.

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 to each country and site requirements Perform IRB/EC (CA) 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