other
Posted 1 weeks agoSite Start-Up Specialist
at Fortrea
Hybrid
Responsibilities
- 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.
Requirements
- Qualifications: To succeed in this role, you should have: 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 .
- Experience interacting with regulatory authorities and site start-up teams.
- Proficiency in Microsoft Office and document management systems .
- Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements.
Benefits
- What We Offer: Competitive salary and performance-based incentives.
Additional details
- 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.
- In this role, you will be part of our FSPx team and work directly with one of our renowned key sponsor to advance the development of innovative, life-changing medications. Key