Lead Clinical Research Associate - Remote

Overview

The Lead Clinical Research Associate is responsible for coordinating site feasibility, monitoring project timelines, and ensuring compliance with regulatory guidelines while managing a team of monitors.

In Short

• Coordinates investigator/site feasibility and study startup.
• Monitors patient enrollment and project timelines.
• Reviews monitoring visit reports for compliance.
• Manages query resolution and safety information flow.
• Conducts clinical supplies management with vendors.
• Acts as communication liaison among project teams.
• Conducts site audits and prepares teams for audits.
• Delivers training and presentations at Investigator Meetings.
• Ensures data integrity and compliance at site level.
• Supports regulatory submission package preparation.

Requirements

• Relevant educational background in Life Sciences.
• Minimum 4 years of site monitoring experience.
• Experience managing sites and CRAs in the US.
• Knowledge of US regulatory guidelines.
• Experience with monitoring visits in Phases I-III.
• Strong experience in Oncology preferred.
• Proficiency in MS Office applications.
• Excellent communication and problem-solving skills.
• Ability to travel up to 65% based on project needs.
• Valid driver’s license if applicable.

Benefits

• Stable work environment with a focus on innovation.
• Opportunities for professional development.
• Work with a diverse range of therapeutic indications.
• Collaborative and dynamic team environment.
• Confidentiality of employee information maintained.