Site Start-up Specialist
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Job Description
Site Start-Up Specialist coordinating site activation, regulatory submissions, and essential documents for Fortrea’s clinical research trials. Supporting sponsors, sites, and authorities across Sweden and Nordic countries.
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
- 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
Requirements:
- 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
- Fluency in local language and English
- Fluency in both Swedish and Finnish, or ability to support start-up activities across Finland, Sweden and Norway
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
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