Global Clinical Trials Start-Up Specialist

Fortrea; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Fortrea is seeking a regulatory start-up specialist to manage site activation and ongoing regulatory submissions across assigned countries, supporting EC/IRB submissions and resolving issues with minimal supervision.

You will collect and review essential documents, ensure compliance with ICH/GCP and local regulations, and mentor junior staff while coordinating with project teams to meet timelines.

Qualifications

• University degree in life sciences or related field with 2 years of clinical research experience.
• Strong working knowledge of ICH guidelines, RA, IRB/IEC regulations.
• Alternative: High school diploma with 2 years clinical research experience may be considered.

Responsibilities

• Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
• Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority.
• Compile and prepare routine submissions and liaise with authorities regarding submission/approval.
• Liaise with internal and external vendors for regulatory submissions.
• Ensure start-up and maintenance activities are on track per client expectations and regulations.

Skills

Clinical research

ICH guidelines

IRB/IEC regulations

Protocol communication

Education

Life sciences degree

Related allied health certification

Job description

Fortrea is seeking a regulatory start-up specialist to manage site activation and ongoing regulatory submissions across assigned countries, supporting EC/IRB submissions and resolving issues with minimal supervision.

You will collect and review essential documents, ensure compliance with ICH/GCP and local regulations, and mentor junior staff while coordinating with project teams to meet timelines.