Clinical Nurse Reviewer I
Location: Chennai, India
Job Type: Full-time
Work Model: Office with Flex
Organization: ICON plc
About the Organization
ICON plc is a global healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, medical device, and public health research. The company focuses on advancing clinical trials from molecule development through to marketed therapies, with strong emphasis on patient safety and data quality.
Role Overview
The Clinical Nurse Reviewer I supports clinical trial operations by ensuring accurate collection, review, and preparation of clinical endpoint documentation for adjudication committees.
The role involves reviewing clinical source documents, preparing adjudication dossiers, and ensuring medical completeness for endpoint evaluation in clinical trials.
Key Responsibilities
1. Clinical Endpoint Documentation Management
Ensure timely collection of source documents for adjudication packages
Review and quality-check clinical endpoint documentation for completeness and accuracy
Prepare medically complete adjudication dossiers for physician review
2. Medical Review & Data Handling
Review medical information including:
Clinical conditions
Laboratory results
Procedures and clinical narratives
Ensure proper coding of clinical data (e.g., MedDRA coding)
Identify potential sources of unblinding in clinical data
3. Adjudication Support
Support physician adjudicators by preparing structured clinical cases
Respond to queries from investigators, physicians, and internal teams
Extract endpoint and adverse event data from source documents and electronic systems
4. Reporting & Coordination
Generate progress and status reports for clinical adjudication committees
Track performance and quality metrics across adjudication activities
Collaborate with project management and clinical operations teams
5. Compliance & Regulatory Adherence
Follow Good Clinical Practice (GCP) guidelines
Ensure compliance with FDA regulations, international standards, and company SOPs
Maintain data integrity across all clinical documentation processes
Required Qualifications
Education
Registered Nurse (RN) certification is required
Experience
Minimum 2+ years of experience in:
Clinical research
Drug development
Healthcare or clinical industry
Technical Skills
Familiarity with:
Electronic Data Capture (EDC) systems
eCRFs (electronic case report forms)
Microsoft Office tools
Experience with MedDRA coding (preferred)
Regulatory Knowledge
Understanding of FDA regulations
Knowledge of clinical trial reporting requirements
Familiarity with ICH-GCP guidelines
Soft Skills
Strong attention to detail
Excellent organizational skills
Critical thinking and clinical judgment
Strong verbal and written communication
Ability to work in fast-paced, deadline-driven environments
Preferred Experience
Clinical data management exposure
Experience working with adjudication committees
Exposure to endpoint-driven clinical trials
Core Competencies
Clinical documentation review
Medical data interpretation
Regulatory compliance
Clinical trial support
Cross-functional collaboration
Equal Opportunity Statement
ICON plc is committed to creating an inclusive workplace and provides equal employment opportunities regardless of race, gender, disability, religion, or other protected characteristics.
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