Clinical Research Associate (Level II)

Thermo Fisher Scientific Inc.; São Paulo; Híbrido; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading company in the biotechnology field seeks a Clinical Monitor to manage site operations and ensure compliance with regulatory standards. In this role, you will coordinate all aspects of clinical monitoring, conducting site visits and building relationships with investigational sites. If you have a background in clinical trials and a passion for ensuring quality in research, we encourage you to apply.

Qualificações

• Experience in clinical monitoring and site management required.
• Knowledge of ICH-GCP guidelines and applicable regulations.
• Ability to develop collaborative relationships with site staff.

Responsabilidades

• Conduct remote or on-site visits for protocol compliance.
• Manage required documentation and site procedures.
• Ensure the trial meets regulatory and ethical standards.

Conhecimentos

Protocol compliance

Regulatory compliance

Documentation management

Audit readiness

Relationship building

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.