Site Start-Up Specialist
Fortrea · Budapest, Hungary
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Fortrea seeks a Site Start-Up Specialist to coordinate clinical trial site activities, manage regulatory documentation, and ensure compliance with ICH/GCP guidelines. This role involves direct collaboration with sponsor organizations and investigative sites to facilitate efficient regulatory submissions and site activation across clinical research programs.
What they're looking for
- University or college degree in life sciences, or equivalent allied health certification
- Minimum 2 years of clinical research, regulatory submissions, or site activation experience
- Strong knowledge of ICH/GCP guidelines, regulatory affairs, and IRB/IEC procedures
- Ability to review and adapt informed consent forms for local and protocol requirements
- Experience interacting with regulatory authorities and site start-up teams
- Proficiency in Microsoft Office and document management systems
- Excellent organizational, problem-solving, and communication skills
What you'll be doing
- Serve as primary contact for investigative sites during start-up and maintenance phases
- Collect, review, and organize regulatory documentation for EC/IRB/regulatory authority submissions
- Prepare and submit regulatory documents, including application forms and informed consent materials
- Track submission timelines and address delays proactively
- Ensure documentation is audit-ready and systems remain consistently updated
Privacy & handoff
This role links to Fortrea's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.