AtFortrea we are committed to accelerating clinical trials and ensuring regulatory compliance. As aSite Start-Up Specialistyou 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 theprimary contactfor 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 isaudit-readyand 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 experiencein clinical research regulatory submissions or site activation.
Strong knowledge ofICH/GCP guidelines RA IRB/IEC regulations and start-up processes.
Ability to review and adapt patientinformed consent formsto meet local and protocol-specific requirements.
Experience interacting withregulatory authoritiesand site start-up teams.
Excellentorganizational problem-solving and communication skills.
Proficiency inMicrosoft 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.
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 basisdont miss this opportunity!
Learn more about our EEO & Accommodations request here.
Required Experience:
IC
Start-Up Specialist • Paris, Île-de-France, France
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