CRA (Level I)

Overview

Clinical Research Associate I responsible for monitoring clinical trial sites and managing site activities to support protocol, regulatory, ICH-GCP and documentation compliance.

What you'll do

• Monitor investigator sites using risk-based monitoring, including remote and on-site visits.
• Review data accuracy through source document review, source data verification and case report form review.
• Assess investigational product inventory and records.
• Document observations, escalate deficiencies and follow issues through resolution.
• Initiate, monitor and close clinical trial sites according to project procedures.
• Maintain essential documents, study systems, status tracking and progress reports.
• Facilitate communication among sites, clients and internal project teams.

What you'll need

• Bachelor's degree in a life sciences field, Registered Nursing certification or equivalent qualification.
• 1–2 years of comparable clinical monitoring experience or relevant health sciences experience with formal medical terminology and anatomy training.
• Basic medical or therapeutic-area knowledge and medical terminology skills.
• Working knowledge of ICH-GCP requirements, applicable regulations and procedural documents.
• Critical thinking, root cause analysis and problem-solving skills.
• Good communication, organization, time management and interpersonal skills.
• Microsoft Office proficiency and good English language and grammar skills.

Details

• Location: Singapore
• Work environment: Office, clinical trial site and/or home office
• Travel: Generally 60–80%, with frequent travel to site locations