Clinical Research Associate (Level II)

Position Overview

• Location Type: [Not specified]
• Job Type: Full time
• Salary: [Not specified]
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office

This role performs and coordinates all aspects of the clinical monitoring and site management process. The Clinical Research Associate conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. They manage procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). This position 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. The role also ensures audit readiness and develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to the role are outlined in the task matrix.

Responsibilities

• Perform and coordinate all aspects of the clinical monitoring and site management process.
• Conduct remote or on-site visits to assess protocol and regulatory compliance.
• Manage required documentation.
• Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
• Act as a site processes specialist.
• Ensure trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs.
• Guarantee subjects' rights, well-being, and data reliability.
• Ensure audit readiness.
• Develop collaborative relationships with investigational sites.

Requirements

• [Not specified]

Application Instructions

• [Not specified]

Company Information

• [Not specified]