Clinical Research Associate (Level II)

Thermo Fisher Scientific; Brasil; Presencial; BRL 60.000 - 90.000; Tempo integral

Resumo da oferta

Thermo Fisher Scientific is seeking a clinical monitoring specialist to coordinate site management processes. The role involves ensuring compliance with protocols and guidelines, conducting visits, and building collaborative relationships within clinical research environments.

Qualificações

• Experience in clinical trial monitoring and site management.
• Strong knowledge of ICH-GCP guidelines and applicable regulations.
• Ability to develop relationships with investigational sites.

Responsabilidades

• Conduct remote or on-site visits to assess compliance.
• Manage and document processes from various sponsors.
• Ensure audit readiness and maintain subject safety.

Conhecimentos

Clinical monitoring

Regulatory compliance

Documentation management

Descrição da oferta de emprego

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.