Site Start-Up Specialist - Fsp

### Join Our Team and Drive Clinical Research Success! At**[Fortrea](https://himalayas.app/companies/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.** **This is full time, permanent and home based position.** ### Preferred Candidate Profile: **Fluency in both Swedish and Finnish**, and able to support start-up activities across **Finland, Sweden and Norway**. ### 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](https://himalayas.app/companies/fortrea) may consider relevant and equivalent experience in lieu of educational requirements. * ### Fluency in local language and English. ### What We Offer: * 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. ### 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! Learn more about our EEO & Accommodations request here. Originally posted on [Himalayas](https://himalayas.app)