Site Start-up Specialist

This is a fully remote position, open to applicants in Sweden.

📋 Description

• Act as the main point of contact for investigative sites throughout start-up and operational procedures.

• Gather, assess, and organize essential documents necessary for regulatory submissions.

• Ensure adherence to ICH/GCP standards, regulatory mandates, and sponsor requirements.

• Prepare and file regulatory documentation, including country-specific application forms and informed consent documents.

• Monitor submission schedules and proactively manage any potential delays.

• Collaborate with both internal and external stakeholders, such as vendors, clinical teams, and regulatory agencies.

• Ensure that all documentation is audit-ready and that systems remain consistently updated.

• Assist in negotiating site contracts and budgets when necessary.

• Provide mentorship and training to new employees and less experienced team members.

⛳️ Requirements

• Bachelor’s degree or equivalent (preferably in life sciences) or certification in a related allied health field.

• At least 2 years of experience in clinical research, regulatory submissions, or site activation.

• Strong understanding of ICH/GCP guidelines, regulatory affairs, IRB/IEC regulations, and start-up processes.

• Ability to review and modify patient informed consent forms to comply with local and protocol-specific standards.

• Experience in engaging with regulatory authorities and site start-up teams.

• Exceptional organizational, problem-solving, and communication abilities.

• Proficient in Microsoft Office and document management systems.

• Fortrea may accept relevant and equivalent experience as a substitute for educational qualifications.

• Proficiency in the local language and English is required.

• Fluency in both Swedish and Finnish, or capability to support start-up activities across Finland, Sweden, and Norway.

🏝️ Benefits

• Competitive salary along with performance-based incentives.

• Flexible work options (remote/hybrid arrangements available).

• Opportunities for professional development within a collaborative and innovative setting.

• The chance to participate in advanced clinical research projects.