Remote-Eligible Study Start-Up Specialist

FTINC Fortrea Inc.; North Carolina; On-site; USD 50,000 - 70,000; Full time

Job summary

Fortrea Inc. is seeking a Study Start Up Specialist with 2+ years of start-up experience in the U.S. You will be the primary contact for investigative sites, collecting required documents and guiding submissions to EC/IRB/Regulatory Authorities while ensuring timelines and quality standards.

You will mentor newer staff, stay current with regulatory standards, and support site activation strategies across countries as needed.

Qualifications

• 2+ years' work experience in clinical research with knowledge of ICH guidelines and RA, IRB/IEC regulations.
• University/College degree in life sciences or related allied health field; high school diploma with 2+ years clinical research experience considered.
• Experience in start-up/regulatory processes and interaction with investigative sites.

Responsibilities

• Act as primary contact for investigative sites during start-up activities and maintenance.
• Collect and organize regulatory documents for EC/IRB/Regulatory Authority submissions within timelines.
• Coordinate submissions and liaise with regulators and internal teams to ensure compliance.
• Mentor and train new hires and less-experienced colleagues where suitable.
• Assist in strategy definition for site activation and provide timelines to study teams.

Skills

ICH guidelines

RA / Regulatory Authority

IRB / IEC regulations

Start-up coordination

Contract & budgets negotiation

Education

Life science degree

Job description

Fortrea Inc. is seeking a Study Start Up Specialist with 2+ years of start-up experience in the U.S. You will be the primary contact for investigative sites, collecting required documents and guiding submissions to EC/IRB/Regulatory Authorities while ensuring timelines and quality standards.

You will mentor newer staff, stay current with regulatory standards, and support site activation strategies across countries as needed.