Remote Site Start-Up Specialist – Clinical Trials

Fortrea; Paris; Hybride; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

Flexible work arrangements (remote/hyb

Professional growth opportunities

Cutting-edge clinical research

Résumé du poste

Fortrea is seeking a Site Start-Up Specialist I to coordinate site activation, manage essential regulatory documents, and ensure submissions are completed efficiently. You will support ICH/GCP-compliant processes and work with sponsor teams to advance clinical trials.

This role involves audit-ready documentation, contract and budget input, and mentoring new hires within a collaborative, remote/hybrid team focusing on life-changing therapies.

Qualifications

• University/College degree in life sciences or related allied health profession, or certification.
• Minimum 18 months 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 informed consent forms to local and protocol-specific requirements.
• Experience interacting with regulatory authorities and site start-up teams.

Responsabilités

• 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.

Connaissances

Regulatory submissions

ICH/GCP guidelines

Site start-up coordination

Documentation management

Vendor coordination

Regulatory authorities liaison

Microsoft Office

Formation

University/College degree (life sciences preferred)

Outils

Document management systems

Regulatory databases

Description du poste

Fortrea is seeking a Site Start-Up Specialist I to coordinate site activation, manage essential regulatory documents, and ensure submissions are completed efficiently. You will support ICH/GCP-compliant processes and work with sponsor teams to advance clinical trials.

This role involves audit-ready documentation, contract and budget input, and mentoring new hires within a collaborative, remote/hybrid team focusing on life-changing therapies.