ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing and improving patients’ lives. With a commitment to innovation and excellence, ICON fosters an inclusive work environment that drives success in drug development. The company’s core values—Accountability & Delivery, Collaboration, Partnership, and Integrity—make it a preferred partner in clinical research.
Job Description
ICON plc is seeking a Clinical Nurse Reviewer I to join its dynamic team. This role involves managing the collection, processing, and analysis of clinical data for Clinical Events Committees (CEC) in endpoint-driven trials. The position is home-based and open to candidates in Bengaluru, Chennai, or Trivandrum.
Key Responsibilities:
- Ensure timely collection and quality control of Adjudication Packages for Clinical Endpoint Committees.
- Review and compile medically complete dossiers for physician adjudicators.
- Respond to queries from physicians, clinical site personnel, and internal teams regarding dossier components.
- Collaborate with project management to generate status reports, track committee performance, and maintain documentation.
- Ensure compliance with Good Clinical Practices (GCP), FDA regulations, and company SOPs.
- Extract and interpret endpoint/adverse event (AE) data from source documents.
- Prepare narrative summaries and ensure accurate MedDRA coding in the CEC database.
Qualifications & Skills:
- Registered Nurse (RN) qualification with 2+ years of experience in clinical research or drug development.
- Strong critical thinking and analytical skills.
- Experience with FDA regulations, MedDRA coding, and electronic data capture (eCRFs) is preferred.
- Proficiency in Microsoft Office and data management tools.
- Excellent verbal and written communication skills.
- Detail-oriented with strong organizational abilities.
Why Join ICON plc?
ICON offers a supportive work environment, competitive salaries, and comprehensive benefits, including:
- Health insurance for employees and families.
- Retirement plans and life assurance.
- Global Employee Assistance Program (EAP)Â for well-being support.
- Flexible benefits (childcare vouchers, gym discounts, travel passes).
- Inclusive workplace promoting diversity and equal opportunity.