Job Description

Fortrea is growing! For one of our client we are currently looking for a Start-Up Specialist to join our team.

Responsibilities (but not only):

• Compile and prepare routine submission filed
• Liaise with internal and external vendors
• Perform a review of final submission documents as applicable.
• Ensure that all assigned start-up and maintenance activities are on track
• Prevent and escalate study issues appropriately and in a timely fashion
• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
• Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision

Experience (Minimum Required):

• Minimum of 2 years of experience in clinical development or start-up/ regulatory process
• Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites

Learn more about our EEO & Accommodations request here