Lead Clinical Research Associate - Remote

Overview

The Lead Clinical Research Associate at PSI coordinates various aspects of clinical trials, ensuring compliance and data integrity while managing a team and communication with various stakeholders.

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.
• Coordinates safety information flow and reporting.
• Conducts site audits and prepares for them.
• Leads project team calls and provides updates.
• Ensures data integrity and compliance.
• Conducts project-specific training for site Investigators.
• Supports regulatory submission preparations.

Requirements

• Relevant educational background (MD, MPharm, RN, or equivalent).
• Minimum of 5 years’ site monitoring experience.
• Experience with Phase II and/or III monitoring visits.
• Strong experience in Oncology preferred.
• Experience in CAR-T Therapy or other cell therapies preferred.
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Strong communication and problem-solving skills.
• Ability to travel up to 50% depending on project needs.
• Valid driver’s license (if applicable).

Benefits

• Opportunity to work with a leading Contract Research Organization.
• Focus on stability and innovation.
• Supportive work environment.
• Career development opportunities.
• Engagement in diverse therapeutic indications.