Clinical Research Associate (CRA I / CRA II) – Office with Flex | Mumbai, India
Job ID: JR135624
Location: Mumbai, India
Employment Type: Full-Time
Work Model: Office-Based with Flexibility
Company: ICON plc
About ICON plc
ICON plc is a leading global contract research organization (CRO) delivering healthcare intelligence and clinical development solutions to pharmaceutical, biotechnology, and medical device companies. With a strong global presence, ICON supports Phase I–IV clinical trials across multiple therapeutic areas, ensuring regulatory compliance, data integrity, and patient safety.
Position Overview
ICON plc is hiring Clinical Research Associates (CRA I / CRA II) to support oncology and immunology clinical trials in Mumbai. This role involves on-site monitoring, site management, and oversight of clinical trial activities to ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements.
The CRA will play a critical role in maintaining data accuracy, ensuring participant safety, and facilitating smooth coordination between sponsors, investigators, and cross-functional teams.
Experience Required
Minimum 3 years of experience as a Clinical Research Associate with hands-on on-site monitoring experience.
Prior experience in Oncology and/or Immunology therapeutic areas is mandatory.
Proven experience conducting monitoring visits independently.
Key Responsibilities
Conduct Site Qualification Visits (SQV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).
Ensure adherence to study protocols, regulatory requirements, and ICH-GCP standards.
Perform source data verification (SDV) and resolve data queries to maintain high-quality clinical datasets.
Collaborate with principal investigators and site staff to ensure effective trial execution.
Review and contribute to essential study documentation, including protocols and clinical study reports.
Identify and escalate site performance issues and support corrective action implementation.
Maintain inspection readiness and compliance throughout the study lifecycle.
Required Qualifications & Skills
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related healthcare discipline.
Strong knowledge of clinical trial processes, regulatory frameworks, and Good Clinical Practice (ICH-GCP).
Excellent organizational, documentation, and communication skills.
Ability to manage multiple study sites and work in a fast-paced environment.
Willingness and ability to travel up to 60% (domestic and international travel, including fly-and-drive).
Valid driver’s license required.
Core Skills & SEO Keywords
CRA Jobs Mumbai, Clinical Research Associate India, Oncology Clinical Trials, Immunology Studies, On-Site Monitoring Jobs, ICH-GCP Compliance, CRO Careers India, Phase II–IV Trials, Clinical Monitoring Careers.
Why Join ICON plc
ICON offers competitive compensation and comprehensive country-specific benefits designed to promote employee well-being and career growth, including:
Annual leave entitlements
Health insurance options
Retirement planning programs
Life assurance coverage
Global Employee Assistance Programme (TELUS Health)
Flexible optional benefits based on region
ICON is committed to fostering an inclusive and discrimination-free workplace where all qualified applicants receive equal employment opportunities.
How to Apply
Experienced Clinical Research Associates with Oncology or Immunology expertise are encouraged to apply through the official ICON careers portal.
For more global Clinical Research, CRA, and CRO job opportunities, visit ThePharmaDaily.com.
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