Start-Up Specialist I - Sponsor dedicated

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): Learn more about our EEO & Accommodations request here . - 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 investi...