Remote CRA II: Hybrid Clinical Trial Monitor

Lightship; Durham (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Lightship is a clinical trial site organization delivering on-site, hybrid, and virtual trials. The CRA II monitors trial sites to ensure adherence to protocols, ICH-GCP, regulatory requirements, and Lightship SOPs, serving as the main contact for investigator sites.

This remote role requires travel to sites for visits, investigator meetings, audits, and other study-related activities (approximately 25-50%).

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Health Sciences, Clinical Research, or related field (required).
• Minimum 4 years of clinical research experience.
• Minimum 2-4 years of independent monitoring experience.

Responsibilities

• Perform SDV/SDR to ensure data accuracy, completeness, and traceability.
• Review eCRFs, source docs, study records, and essential documents.
• Identify data trends, discrepancies, and quality concerns.
• Collaborate with study teams to resolve queries and data issues promptly.
• Ensure compliance with ALCOA+ data integrity principles.

Skills

ICH-GCP knowledge

FDA regulations knowledge

Risk-based monitoring

Study coordination

Data quality oversight

Communication skills

Independent site management

Education

Bachelor's degree in Life Sciences, Nursing, Health Sciences, Clinical Research, or related field

Tools

EDC systems

Microsoft Office

Job description

Lightship is a clinical trial site organization delivering on-site, hybrid, and virtual trials. The CRA II monitors trial sites to ensure adherence to protocols, ICH-GCP, regulatory requirements, and Lightship SOPs, serving as the main contact for investigator sites.

This remote role requires travel to sites for visits, investigator meetings, audits, and other study-related activities (approximately 25-50%).