**Job Overview:** 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 Responsibilities:** In this role, you will: * 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. **Required 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** . * 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** . * Fortrea may consider relevant and equivalent experience in lieu of educational requirements. **What We Offer:** * Competitive salary and performance\-based incentives. * Professional growth opportunities in a collaborative and innovative environment. * The opportunity to work on cutting\-edge clinical research projects. Learn more about our EEO \& Accommodations request here .
David Muñoz
Indeed · HR
David Muñoz
Indeed · HR
