Lead Clinical Research Associate

Job Summary

Overseeing and coordinating clinical monitoring activities for assigned trials, the full-time remote Lead Clinical Research Associate will ensure compliance with regulatory requirements, protocol adherence, and data integrity while collaborating closely with CRAs and the study team.

Key responsibilities

• Support the planning, scheduling, and tracking of clinical monitoring visits
• Collaborate with the Data Management team to oversee data processing and query resolution
• Develop and implement the Clinical Monitoring Plan, including risk identification and mitigation strategies

Required qualifications

• Bachelor's degree in a scientific or healthcare-related field preferred
• Minimum of 5 years of experience in clinical research, with at least 2 years in a Senior CRA role preferred
• Thorough knowledge of regulations governing clinical research (e.g., FDA, Health Canada) and ICH GCP
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems
• Certification in Clinical Research (e.g., CCRP, CCRA) is preferred