Clinical Research Associate I/II (CRA) | ICON plc
Company: ICON plc Careers
Job ID: JR135624
Position: Clinical Research Associate I / II
Location: India (site-based / travel role)
Functional Area: Clinical Research / Clinical Operations
Employment Type: Full-Time | Regular
Role Overview
The Clinical Research Associate (CRA I/II) at ICON plc is responsible for site-level clinical trial management and monitoring, ensuring that studies are conducted according to:
Study protocol
ICH-GCP guidelines
Regulatory requirements
Patient safety standards
This is a field-based clinical operations role with significant travel and direct interaction with investigator sites.
Key Responsibilities
1. Site Monitoring Activities
Conduct site qualification visits (SQV)
Perform site initiation visits (SIV)
Execute routine monitoring visits
Conduct close-out visits
Ensure proper trial conduct at all assigned sites.
2. Patient Safety & Compliance
Ensure patient safety is maintained throughout the study
Verify informed consent processes
Ensure protocol adherence at site level
Identify and escalate safety or compliance issues
3. Data Quality & Integrity
Review clinical trial data for accuracy and completeness
Perform source data verification (SDV)
Resolve data queries with site teams
Ensure consistency between source data and case report forms (CRFs)
4. Investigator & Site Coordination
Collaborate with investigators and site staff
Provide guidance on protocol execution
Support smooth study operations across sites
Maintain strong site relationships
5. Documentation & Reporting
Contribute to study documentation (protocols, reports)
Support clinical study report inputs
Maintain monitoring visit reports
Ensure regulatory inspection readiness
Required Qualifications
Education
Bachelor’s degree in a scientific or healthcare-related field
Experience
Minimum 3 years of experience as a CRA
Hands-on on-site monitoring experience required
Experience in Oncology or Immunology (mandatory)
Technical Knowledge
Strong understanding of:
Clinical trial lifecycle
ICH-GCP guidelines
Regulatory compliance requirements
Site monitoring processes
Source data verification (SDV)
Clinical documentation standards
Soft Skills
Strong attention to detail
Excellent communication skills
Ability to work independently
Strong organizational skills
Stakeholder management (site-level)
Ability to perform in fast-paced environments
Travel Requirements
At least 60% travel required
Domestic and international travel (fly and drive)
Valid driver’s license required
Role Characteristics
This is a traditional CRA field-monitoring role, focused on:
Site oversight (not centralized analytics)
Direct interaction with investigators
Protocol compliance enforcement
Hands-on clinical operations execution
What ICON Offers
At ICON plc, employees benefit from:
Competitive compensation
Health insurance coverage options
Retirement planning support
Global employee assistance programs
Flexible benefits (country-specific)
Work-life balance initiatives
Why This Role Matters
This role directly contributes to:
Execution of global clinical trials
Patient safety in real-world trial settings
High-quality clinical data generation
Regulatory approval readiness of new therapies
Helpful Link
Careers
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