Position Summary

The Lead Clinical Research Associate (Lead CRA) is responsible for leading site monitoring activities across assigned clinical trials while ensuring compliance with International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, company SOPs, and regulatory requirements. The Lead CRA serves as the primary liaison between the sponsor and investigative sites, providing oversight, mentoring CRAs, and supporting clinical trial execution.

Key Responsibilities

Clinical Trial Monitoring

• Lead and conduct site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensure compliance with protocols, regulatory requirements, and GCP guidelines.
• Review source documentation and Case Report Forms (CRFs) for accuracy and completeness.
• Track patient enrollment, protocol adherence, and data quality.

Leadership & Oversight

• Act as the lead CRA on assigned studies, coordinating monitoring activities across multiple sites.
• Provide mentorship and training to junior CRAs.
• Assist clinical project managers with study planning, timelines, and monitoring strategies.
• Participate in investigator meetings and sponsor oversight meetings.

Site & Investigator Management

• Serve as the primary contact for study investigators and site staff.
• Ensure sites are properly trained on protocols and study procedures.
• Identify and resolve site performance issues and protocol deviations.

Regulatory & Documentation

• Ensure compliance with regulatory authorities such as the U.S. Food and Drug Administration (FDA).
• Maintain accurate Trial Master File (TMF) documentation.
• Prepare monitoring reports and follow-up letters.

Risk Management & Quality

• Identify risks related to patient safety, data integrity, or protocol compliance.
• Support audit and inspection readiness.
• Collaborate with clinical operations, data management, and medical teams.

Required Qualifications

Education

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field.

Experience

• Typically 5–8+ years of clinical research monitoring experience.
• Experience working in biotechnology, pharmaceutical, or CRO environments.