Site Start up Specialist- FSP Model- Spain

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.

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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.

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Key Responsibilities

In this role, you will

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Serve as the primary contact for investigative sites during start-up and maintenance activities.

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Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).

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Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.

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Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.

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Track submission timelines and proactively address potential delays.

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Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.

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Ensure all documentation is audit-ready and systems are consistently updated.

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Assist in the negotiation of site contracts and budgets, if applicable.

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Provide mentorship and training to new hires and less-experienced colleagues.

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Required Qualifications

To succeed in this role, you should have

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University/College degree (life sciences preferred) or certification in a related allied health profession.

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Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.

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Mandatory experience in ICF adaptation and management of CTIS / EU-CTR

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Mandatory experience in preparation and management of submissions packages independently.

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Experience interacting with regulatory authorities and site start-up teams.

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Excellent organizational, problem-solving, and communication skills .

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Proficiency in Microsoft Office and document management systems .

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Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

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What We Offer

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Competitive salary and performance-based incentives.

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Professional growth opportunities in a collaborative and innovative environment.

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The opportunity to work on cutting-edge clinical research projects.

Learn more about our EEO & Accommodations request here .