Clinical Research Associate (CRA I / CRA II) – Clinical Monitoring & Trial Execution
Location: Mumbai, India
Job Type: Full-Time | Office with Flex
Company: ICON plc
Job ID: JR135624
About the Role
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Clinical Research Associate (CRA I / CRA II) to support end-to-end clinical trial monitoring and execution. This role is critical in ensuring protocol compliance, patient safety, and high-quality data across clinical studies.
You will work closely with investigators, site teams, and cross-functional stakeholders to ensure smooth study conduct and regulatory compliance across assigned clinical trials.
Key Responsibilities
Conduct site qualification, site initiation, monitoring, and close-out visits
Ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements
Monitor patient safety, data integrity, and site performance throughout the trial lifecycle
Collaborate with investigators and site staff to support efficient trial execution
Perform data review and resolve queries to maintain high-quality clinical data
Assist in preparation and review of study documents including protocols and clinical study reports
Maintain accurate documentation and monitoring reports
Support audit and inspection readiness activities
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, or a healthcare-related field
Minimum 3+ years of experience as a Clinical Research Associate with strong on-site monitoring experience
Mandatory experience in Oncology or Immunology therapeutic areas
Strong knowledge of clinical trial processes, ICH-GCP, and regulatory guidelines
Proven ability to manage site relationships and ensure compliance
Excellent organizational, communication, and problem-solving skills
Ability to work independently and within cross-functional teams
Willingness to travel up to 60% (domestic and international)
Valid driver’s license required
Preferred Skills
Experience in multi-site or global clinical trials
Strong understanding of risk-based monitoring approaches
Ability to manage multiple studies simultaneously
Why Join ICON
ICON provides a dynamic and collaborative environment where clinical research professionals contribute to advancing innovative therapies and improving patient outcomes.
Key Benefits Include
Competitive salary and career advancement opportunities
Flexible work environment
Generous leave policies
Comprehensive health insurance
Retirement and financial planning benefits
Global Employee Assistance Programme (24/7 support)
Life insurance and wellness initiatives
Flexible, country-specific employee benefits
Diversity, Equity & Inclusion
ICON is committed to building an inclusive workplace. All qualified applicants will receive equal opportunity without discrimination.
Application Note
Candidates who may not meet all requirements are encouraged to apply. ICON values diverse experience and supports continuous professional development.
This role is ideal for experienced CRAs seeking to advance their careers in clinical monitoring, site management, and global trial execution within a leading CRO.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Sheffield |Oxfordshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
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Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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