Clinical Research Associate (CRA I / CRA II) – Oncology / Immunology
Location: Mumbai, India
Work Model: Office with Flex
Employment Type: Full-Time
Job ID: JR135624
Company: ICON plc
ThePharmaDaily.com is featuring an opportunity for Clinical Research Associate (CRA I / CRA II) with ICON plc, a globally recognized clinical research organization (CRO) driving innovation in clinical development. This role is ideal for experienced CRAs with strong on-site monitoring expertise and mandatory therapeutic area exposure in Oncology or Immunology.
Experience Required
Minimum 3+ years of experience as a Clinical Research Associate with hands-on on-site monitoring experience in clinical trials. Oncology or Immunology therapeutic area experience is mandatory.
Job Overview
The CRA I / CRA II will be responsible for the end-to-end management of assigned clinical trial sites, ensuring regulatory compliance, protocol adherence, data integrity, and patient safety. The role involves active site monitoring, investigator collaboration, and oversight of clinical trial conduct in accordance with ICH-GCP and applicable regulatory guidelines.
This position requires strong organizational skills, the ability to manage multiple sites, and flexibility to travel extensively.
Key Responsibilities
Conduct site qualification, site initiation, routine monitoring, and close-out visits
Ensure compliance with study protocols, SOPs, ICH-GCP, and regulatory requirements
Monitor patient safety, data accuracy, and overall site performance
Perform source data verification (SDV) and resolve data queries in collaboration with site staff
Maintain high standards of data integrity and documentation
Collaborate with investigators and site coordinators to support efficient study conduct
Contribute to the preparation and review of clinical trial documentation including protocols and clinical study reports
Provide regular updates to project teams regarding site status and risk mitigation
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a healthcare-related discipline
Minimum 3 years of Clinical Research Associate experience with on-site monitoring
Mandatory experience in Oncology or Immunology therapeutic area
Strong knowledge of clinical trial processes, regulatory frameworks, and ICH-GCP guidelines
Excellent communication and interpersonal skills
Strong organizational abilities and attention to detail
Ability to work independently and in cross-functional global teams
Willingness to travel up to 60% (domestic and international travel as required)
Valid driver’s license
Core Competencies
Clinical trial monitoring
Site management and compliance oversight
Oncology and Immunology trial experience
ICH-GCP and regulatory compliance
Risk-based monitoring
Data integrity and patient safety management
Cross-functional clinical collaboration
Compensation and Benefits
ICON offers competitive compensation aligned with industry benchmarks. Benefits are country-specific and designed to support employee well-being and long-term financial security. These may include:
Annual leave entitlements
Health insurance coverage
Retirement and savings plans
Life assurance
Global Employee Assistance Programme (TELUS Health)
Flexible optional benefits such as wellness programs, childcare support, gym memberships, and travel subsidies
Equal Opportunity Statement
ICON is committed to fostering an inclusive, accessible, and discrimination-free workplace. All qualified applicants will receive equal consideration without regard to race, religion, gender, disability, veteran status, or other protected characteristics. Reasonable accommodations are available throughout the recruitment process.
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