Site Start-up Specialist - FSP

Key Responsibilities:

In this role, you will:

• Serve as the

for investigative sites during start-up and maintenance activities.

• Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).
• Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
• Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.
• Track submission timelines and proactively address potential delays.
• Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.
• Ensure all documentation is

and systems are consistently updated.

• Assist in the negotiation of site contracts and budgets, if applicable.
• Provide mentorship and training to new hires and less-experienced colleagues.

in clinical research, regulatory submissions, or site activation.

• Strong knowledge of

.

• Ability to review and adapt patient

to meet local and protocol-specific requirements.

• Experience interacting with

and site start-up teams.

• Excellent

.

• Proficiency in

.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluency in local language and English.

• Competitive salary and performance-based incentives.
• Flexible work arrangements (remote/hybrid options).
• Professional growth opportunities in a collaborative and innovative environment.
• The opportunity to work on cutting-edge clinical research projects.