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.
Required Experience:
IC
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 filedLiaise with internal and external vendorsPerform a review of final submission documents as applicable.Ensure that ...
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.
Required Experience:
IC
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