Associate – Regulatory Affairs
CLINCHOICE
Advertisement
Job Description
Location: Bangalore, India
Job ID: JR137944
Company: ICON plc
Department: Clinical Monitoring — ICON Strategic Solutions
Work Model: Remote / Field-based
Job Overview
ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to shaping the future of clinical development. As a Clinical Research Associate 1 (CRA 1), you will play a vital role in managing, monitoring, and coordinating clinical trials while ensuring adherence to regulatory standards, patient safety, and data integrity.
This position offers an opportunity to work in a collaborative, innovation-driven environment that fosters professional growth and values diversity and inclusion.
Role & Responsibilities
- Coordinate all start-up and monitoring activities for clinical studies, ensuring compliance with study protocols and regulatory guidelines.
- Complete study status reports accurately and maintain thorough documentation of all study-related activities.
- Manage and resolve sponsor-generated queries efficiently to support study progress.
- Participate in study feasibility assessments and contribute to the preparation and review of study documentation.
- Build and maintain collaborative relationships with investigators, site staff, and other key stakeholders.
- Ensure patient safety and data quality through adherence to ICON’s SOPs, ICH-GCP guidelines, and regulatory requirements.
- Support the team in achieving cost efficiency and timely delivery of study milestones.
Educational Qualification
- Education: University degree in Medicine, Life Sciences, or equivalent discipline.
- Experience: 1–4 years of experience in onsite monitoring.
- Knowledge: Strong understanding of ICH-GCP guidelines and ability to interpret medical data.
Location
 Bangalore, India
Advertisement
Recent Jobs
Clinical Research Coordinator
MS Clinical Research
Safety Science Coordinator I
Fortrea
R&D Operations – Analyst 1
Johnson&Johnson
Medical Advisor
Abbott