Remote Clinical Start-Up Specialist

Fortrea; Madrid; Híbrido; EUR 42.000 - 64.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Flexible work arrangements

Professional growth opportunities

Exposure to cutting-edge clinicals

Descripción de la vacante

Fortrea is seeking a Site Start-Up Specialist to coordinate site activation, manage essential documents, and ensure timely regulatory submissions. You will work with the FSPx team and regulatory authorities to accelerate clinical trials.

The ideal candidate will have a life sciences background, 2+ years in clinical research, and strong organizational and communication skills. This role offers flexible work arrangements and exposure to cutting-edge projects in a collaborative environment.

Formación

• Degree in life sciences or allied health field.
• Minimum 2 years in clinical research, regulatory submissions, or site activation.
• Strong knowledge of ICH/GCP, RA, IRB/IEC regulations, and start-up processes.
• Ability to adapt patient informed consent forms to local/protocol needs.
• Experience interacting with regulatory authorities and site start-up teams.
• Excellent organizational, problem-solving and communication skills.

Responsabilidades

• Serve as primary contact for investigative sites during start-up and maintenance.
• Collect and organize documents for regulatory submissions (EC/IRB/Third Party/RA).
• Ensure compliance with ICH/GCP and sponsor requirements.
• Prepare and submit regulatory documents incl. country forms and ICFs.
• Track submission timelines and address delays proactively.
• Collaborate with vendors, clinical teams, and regulatory authorities.
• Keep documentation audit-ready and systems updated.
• Assist in site contracts and budgets negotiations if applicable.
• Provide mentorship and training to new staff.

Conocimientos

Regulatory submissions

ICH/GCP knowledge

Project coordination

Communication skills

Documentation management

Regulatory authority liaison

Microsoft Office

Educación

Life sciences degree or allied health certification

Herramientas

Document management systems

Descripción del empleo

Fortrea is seeking a Site Start-Up Specialist to coordinate site activation, manage essential documents, and ensure timely regulatory submissions. You will work with the FSPx team and regulatory authorities to accelerate clinical trials.

The ideal candidate will have a life sciences background, 2+ years in clinical research, and strong organizational and communication skills. This role offers flexible work arrangements and exposure to cutting-edge projects in a collaborative environment.