Principal Regulatory Affairs, Study Start Up Specialist

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

What You'll Do

• Study Document Preparation
  • Coordinate with sponsor and Project Management Team to prepare and submit the required core documents across all regions.
  • Develop and maintain the Regulatory Clinical Trial Submission Plan regionally and globally.
  • Prepare review and adapt: Study Informed Consent Forms (ICF).
  • Collaborate with Site Budgets and Contracts teams to prepare globa...