Clinical Research Associate I - Clinical Research Associate II

Overview

The Clinical Research Associate (CRA) role encompasses comprehensive oversight of study site activities including routine monitoring, site closeout, maintaining study documentation, conducting pre-study assessments and initiation visits, coordinating with vendors, and fulfilling additional assigned tasks. The position demands adherence to project plans to manage clinical sites effectively.

Key Responsibilities

• Carry out all monitoring duties at study locations, ensuring adherence to study protocols and regulatory standards.
• Supervise site management as outlined in project directives.

Qualifications and Expertise

• Possess a university or college degree, or an accredited certification in allied health fields such as nursing licensure. Equivalent professional experience may substitute formal education.
• Have a solid grasp of ICH Good Clinical Practice (GCP) guidelines and regional regulatory frameworks.
• Demonstrate thorough knowledge of monitoring methods and basic clinical trial procedures.
• Fluent communication skills in both English and the local office language, oral and written.

Experience Requirements

• External applicants must hold relevant academic qualifications plus a minimum of one year experience in clinical monitoring.
• Internal applicants should have at least one year of clinical monitoring experience.
• Exhibit capability to independently oversee study site monitoring according to plans, standards operating procedures (SOPs), ICH GCP, and project needs.
• Work autonomously with minimal supervision.
• Understand the Serious Adverse Event (SAE) reporting processes including report preparation, narrative generation, and follow-up.
• Show strong organizational, planning, and problem-solving skills.
• Operate efficiently within a matrix organizational structure.

Additional Information

• The role requires travel approximately 60% of the time to visit study sites.

Fortrea is committed to Equal Employment Opportunity and provides accommodations upon request.