Global Clinical Study Start-Up Specialist

Fortrea; United States; Remote; USD 50,000 - 70,000; Full time

Job summary

Fortrea is seeking a Study Start Up Specialist to manage site start-up activities and regulatory submissions in the United States. You will collect essential documents, liaise with IRBs/ECs and regulatory authorities, and ensure compliance with ICH/GCP and sponsor timelines.

The role also involves mentoring junior staff and coordinating with project teams. The ideal candidate has at least 2 years in clinical research, strong knowledge of regulatory requirements, and the ability to work in a

Qualifications

• 2 years’ work experience in clinical research and knowledge of ICH guidelines and RA/IRB regulations.
• Education may be substituted with equivalent experience supporting regulatory submissions.
• Experience with site start-up activities and regulatory authority interactions is preferred.

Responsibilities

• Serve as primary contact with investigative sites during start-up activities and maintenance.
• Coordinate data and documents for EC/IRB/Regulatory Authority submissions.
• Prepare country-specific applications and cover letters for sponsor review.
• Liaise with vendors and review submission documents for consistency and compliance.
• Ensure all start-up activities comply with laws, guidelines, and quality standards.
• Mentor and train new hires and less-experienced team members where suitable.

Skills

Clinical research experience

Regulatory submissions knowledge

ICH/GCP familiarity

Project coordination

Education

University/College degree (life science preferred)

Certification in allied health profession

Job description

Fortrea is seeking a Study Start Up Specialist to manage site start-up activities and regulatory submissions in the United States. You will collect essential documents, liaise with IRBs/ECs and regulatory authorities, and ensure compliance with ICH/GCP and sponsor timelines.

The role also involves mentoring junior staff and coordinating with project teams. The ideal candidate has at least 2 years in clinical research, strong knowledge of regulatory requirements, and the ability to work in a