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.
Mandatory experience in ICF adaptation and management of CTIS / EU-CTR
Mandatory experience in preparation and management of submissions packages independently.
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.