Lead Clinical Research Associate - Remote

Overview

The Lead Clinical Research Associate will coordinate clinical trial activities, ensuring compliance with regulatory standards and effective communication among project teams and trial sites.

In Short

• Coordinates investigator/site feasibility and study startup.
• Monitors project timelines and patient enrollment.
• Reviews monitoring visit reports for compliance.
• Manages query resolution processes.
• Coordinates safety information flow and reporting.
• Conducts clinical supplies management.
• Acts as the main communication line for project teams.
• Conducts training and mentoring for new Lead CRAs.
• Ensures data integrity and compliance at site level.
• Supports regulatory submission preparations.

Requirements

• Relevant educational background (MD, MPharm, RN, or Life Sciences).
• Minimum of 5 years’ site monitoring experience.
• Experience with US regulatory guidelines.
• Strong experience in Oncology preferred.
• Experience in CAR-T Therapy or other advanced therapies preferred.
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Excellent communication and problem-solving skills.
• Ability to travel up to 65%.
• Valid driver’s license (if applicable).

Benefits

• Opportunity to work in a growing company focused on employee development.
• Balance between stability and innovation in the workplace.