[Hiring] Site Start-up Specialist @Fortrea

Role Description

Join Our Team and Drive Clinical Research Success! At Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life-changing treatments to patients faster.

This is a full-time, permanent, and home-based position.

Key Responsibilities:

• Serve as the primary contact 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 audit-ready 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.

Qualifications

• University/College degree (life sciences preferred) or certification in a related allied health profession.
• Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.
• Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
• Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements.
• Experience interacting with regulatory authorities and site start-up teams.
• Excellent organizational, problem-solving, and communication skills.
• Proficiency in Microsoft Office and document management systems.
• Fluency in local language and English.

Requirements

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Benefits

• 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.

Company Description

Ready to Make an Impact? Join us in shaping the future of clinical research. Apply today! Applications are reviewed on a rolling basis—don’t miss this opportunity!