Study Start-Up Specialist II - Site Activation

ICON; Buenos Aires; Híbrido; ARS 63.383.000 - 93.565.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Life assurance

Retirement planning offerings

Global Employee Assistance Programme (

LifeWorks

Descripción de la vacante

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. We are currently seeking a Site Specialist II (Study Start Up Associate II) to join our diverse and dynamic team.

As a Site Specialist I at ICON, you will support investigator sites with key administrative and operational activities to help ensure clinical trials run smoothly, efficiently, and in compliance with applicable regulations.

Formación

• Bachelor’s degree in Life Sciences or equivalent.
• +2 years’ experience or understanding of clinical study start up requirements.
• Knowledge of local and/or international regulatory processes including submissions to regulatory authorities and ethics committees.
• Ability to read and understand clinical protocols, regulatory documents, and study-specific processes.
• Strong attention to detail and organizational skills.
• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.
• Excellent communication skills in English and Spanish.

Responsabilidades

• Collect, review, organize and assemble start-up and maintenance submission packages to EC/IRB, Local EC/IRB and authorities.
• Support assembly of documents for the Critical Document Package (CDP) and site activation.
• Coordinate translations for start-up documentation.
• Progress data entry of documents and site activation tasks into tracking systems.
• Participate in study review meetings and provide updates on site progress.
• Forecast Site Activation plans and keep records in ICON’s systems.
• Ensure TMF documents are complete and QC’d before filing.
• Attend study team meetings as required.

Conocimientos

Attention to detail

Multitasking

Independent worker

Regulatory knowledge

Bilingual English/Spanish

Educación

Bachelor's degree in Life Sciences

Herramientas

TMF systems

Document tracking tools

Descripción del empleo

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. We are currently seeking a Site Specialist II (Study Start Up Associate II) to join our diverse and dynamic team.

As a Site Specialist I at ICON, you will support investigator sites with key administrative and operational activities to help ensure clinical trials run smoothly, efficiently, and in compliance with applicable regulations.