Lead Clinical Research Associate - Remote

Overview

The Lead Clinical Research Associate will coordinate various tasks related to clinical research, ensuring compliance and data integrity while managing project timelines and site interactions.

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 and safety information flow.
• Conducts site audit preparation visits and manages project team.
• Provides training and mentorship for Monitors.
• Ensures accurate information flow with trial sites.
• Supervises data verification and study risk management.
• Supports regulatory submission package preparation.
• Ensures compliance and data integrity at site level.

Requirements

• Relevant educational background (MD, MPharm, RN, or Life Sciences degree).
• Minimum of 4 years’ site monitoring experience.
• Experience with US regulatory guidelines.
• Strong experience in Oncology and other therapies preferred.
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Excellent communication and problem-solving skills.
• Ability to travel up to 65% depending on project needs.
• Valid driver’s license if applicable.

Benefits

• Opportunities for career advancement in clinical research.
• Work in a rapidly growing company that values its employees.
• Gain experience in a variety of therapeutic indications.