Clinical Research Associate

Position Overview

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.

Employment Type

• Full time

Work Schedule

• Standard (Mon-Fri)

Environmental Conditions

• Office

Requirements

• (Information not provided in the original description)

Responsibilities

• 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.
• 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.
• Guarantees subjects' rights, well-being, and data reliability.
• Ensures audit readiness.
• Develops collaborative relationships with investigational sites.
• (Detailed tasks and responsibilities are outlined in the task matrix.)

Application Instructions

• (Information not provided in the original description)

Company Information

• (Information not provided in the original description)