CRA (Level II)

Overview

The Clinical Research Associate (Level II) performs and coordinates clinical monitoring and site management activities, supporting protocol compliance, data reliability, audit readiness, and subject protection.

What you'll do

• Monitor investigator sites using risk-based monitoring, root cause analysis, and corrective actions.
• Review data through source document review, source data verification, and CRF review.
• Assess investigational product inventory and records.
• Document observations and escalate deficiencies through resolution.
• Initiate, monitor, and close clinical trial sites according to protocols and regulations.
• Maintain essential documents, study systems, status reports, and administrative records.
• Facilitate communication among sites, clients, and project teams.

What you'll need

• Bachelor's degree in a life sciences field, Registered Nursing certification, or equivalent relevant qualification.
• At least 2 years of on-site monitoring experience.
• Clinical monitoring skills and knowledge of medical terminology.
• Working knowledge of ICH-GCP, applicable regulations, and procedural documents.
• Critical thinking, root cause analysis, and problem-solving skills.
• Strong communication, organization, interpersonal, and time management skills.
• Microsoft Office knowledge and good English language and grammar skills.

Details

• Work schedule: Monday to Friday.
• Remote, India; the role requires frequent travel, generally 60–80%.
• Work may occur in office, laboratory, clinical, or home-office environments.