Senior Clinical Research Associate (Senior CRA)
Location: Bangalore and Mumbai, India
Work Model: Office with Flex
Employment Type: Full-Time
Job ID: JR144117
Application Deadline: February 20, 2026
Company: ICON plc
ThePharmaDaily.com is featuring a high-impact opportunity for a Senior Clinical Research Associate (Senior CRA) with ICON plc, a globally recognized Clinical Research Organization (CRO) delivering healthcare intelligence and end-to-end clinical development solutions. This role is suited for experienced clinical monitoring professionals with strong expertise in site management, regulatory compliance, and Good Clinical Practice (GCP).
Job Overview
The Senior CRA is responsible for overseeing and managing clinical trial site activities to ensure studies are conducted in accordance with approved protocols, ICH-GCP guidelines, sponsor requirements, and applicable regulatory standards. This position plays a critical role in safeguarding patient safety, ensuring data integrity, and maintaining inspection readiness throughout the clinical trial lifecycle.
Key Responsibilities
Conduct on-site monitoring visits to ensure compliance with study protocols, GCP, and regulatory requirements
Perform site qualification, initiation, routine monitoring, and close-out visits
Evaluate site performance, identify risks, and implement corrective and preventive actions
Ensure accurate and timely data collection, source data verification (SDV), and documentation review
Maintain strong collaboration with Clinical Trial Managers, Data Management, Regulatory Affairs, and other cross-functional teams
Provide training and ongoing support to investigative site staff
Ensure proper reporting of adverse events and protocol deviations
Maintain complete and audit-ready Trial Master File (TMF) documentation
Build and sustain effective relationships with investigators, site coordinators, and stakeholders
Required Qualifications and Experience
Advanced degree in Life Sciences, Nursing, Pharmacy, Medicine, or related field preferred
Minimum 5+ years of experience in on-site clinical trial monitoring as a CRA
Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
Proven ability to manage multiple sites and therapeutic area studies simultaneously
Experience in monitoring practices, data integrity review, and site management
Proficiency in clinical trial management systems (CTMS), EDC systems, and related tools
Excellent organizational, analytical, and problem-solving skills
Strong written and verbal communication skills
Ability to travel up to 60% (domestic and international travel required)
Valid driver’s license required
Core Competencies
Clinical site monitoring and oversight
Risk-based monitoring and compliance management
Patient safety and data quality assurance
Stakeholder communication and relationship management
Audit and inspection readiness
Compensation and Benefits
ICON offers a competitive salary package aligned with industry benchmarks, along with performance-based incentives. Employees benefit from comprehensive country-specific benefits focused on well-being and work-life balance, which may include:
Annual leave entitlements
Health insurance coverage
Retirement planning programs
Life assurance
Global Employee Assistance Programme (TELUS Health)
Flexible optional benefits such as wellness initiatives and subsidized services
Equal Opportunity Statement
ICON is committed to fostering an inclusive and accessible workplace. All qualified applicants will receive equal employment consideration without discrimination based on protected characteristics. Reasonable accommodations are available during the recruitment and employment process where required.
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