Remote Site Start-Up Specialist — Clinical Trials

Fortrea

Paris

Hybrid

EUR 50,000 - 70,000

Full time

14 days+

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Benefits offered by this job

Flexible work arrangements

Professional growth opportunities

Job summary

Fortrea is seeking a Site Start-Up Specialist to coordinate site activation, collect essential regulatory documents, and ensure submission timelines are met. You will work with sponsors and internal teams to drive compliance and audit-ready processes.

Ideal candidates bring 2+ years in clinical research or start-up, strong regulatory knowledge, and excellent organizational skills. Flexible remote/hybrid options are available to support project needs.

Qualifications

Bachelor’s degree in life sciences or related field, or a related allied health certification.
Minimum 2 years of clinical research, regulatory submissions, or site activation experience.
Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
Experience interacting with regulatory authorities and site start-up teams.

Responsibilities

Serve as the primary contact for investigative sites during start-up and maintenance activities.
Collect, review, and organize essential documents 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 address delays.
Collaborate with vendors, clinical teams, and regulatory authorities.
Ensure all documentation is audit-ready and systems are updated.
Assist in site contracts and budgets, if applicable.
Provide mentorship and training to new hires and colleagues.