Lead Clinical Research Associate - Remote

Overview

The Lead Clinical Research Associate coordinates and manages clinical trials, ensuring compliance with regulatory guidelines and overseeing project timelines and patient enrollment.

In Short

• Coordinates investigator/site feasibility and study startup.
• Monitors project timelines and patient enrollment.
• Reviews monitoring visit reports for compliance.
• Manages monitors in query resolution processes.
• Coordinates safety information flow and protocol deviation reporting.
• Ensures timely updates of tracking systems.
• Acts as the main communication line within the project team.
• Conducts site audit preparation visits.
• Leads project team calls and provides status updates.
• Supervises site management associates and training.

Requirements

• Relevant educational background (MD, MPharm, RN, or equivalent).
• Minimum 5 years of site monitoring experience.
• Experience monitoring or managing sites in the USA.
• Experience with monitoring visits in Phases I-III.
• Strong experience in Oncology preferred.
• Experience in CAR-T Therapy or related fields preferred.
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to multitask and work in a team environment.
• Willingness to travel up to 65% based on project needs.

Benefits

• Confidential handling of personal information.
• Opportunity to work in a leading Contract Research Organization.
• Engagement in innovative clinical projects.
• Supportive team environment.
• Professional growth and training opportunities.