Apply for Informed Consent Specialist II at ICON plc Work from Office or Home in India. Join a global CRO ensuring ethical clinical research compliance.
Organization: ICON plc
Position: Informed Consent Specialist II
Location: India (Bangalore, Trivandrum, Chennai)
Job Type: Full-Time | Remote (Office or Home)
Job Requisition ID: JR136801
Experience Required: Minimum 2 years in ICF writing or development
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization (CRO) that works with top global pharmaceutical, biotechnology, and medical device companies. The company is known for its innovation-driven approach to advancing clinical development while maintaining the highest ethical standards. ICON is committed to diversity, inclusion, and excellence, providing a workplace where employees can thrive personally and professionally. Informed Consent Specialist II at ICON plc Work from Office or Home
Job Overview
ICON plc is inviting applications for the position of Informed Consent Specialist II, a crucial role in the ethical and compliant execution of global clinical trials. As an Informed Consent Specialist (ICF Specialist), you will ensure that informed consent documents are accurate, regulatory-compliant, and aligned with study protocols and local requirements. This position is available for candidates who prefer either office or home-based work setups in India. Informed Consent Specialist II at ICON plc Work from Office or Home
Key Responsibilities
- ICF Development and Review: Prepare, review, and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICFs) for global, country-specific, and site-specific versions.
- Regulatory Compliance: Ensure adherence to ICON’s Standard Operating Procedures (SOPs), Working Practices (WPs), ICH/GCP guidelines, and applicable country regulations related to informed consent.
- Cross-Functional Collaboration: Act as a key liaison between Sponsors, Study Start-Up (SSU) Project Managers, Clinical Trial Managers, and other functional leads to ensure timely and compliant project outcomes.
- Query Handling: Review, negotiate, and respond to Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to informed consent documents.
- Timeline Management: Forecast, track, and monitor approval timelines for SIS and ICFs, identifying potential risks and implementing contingency plans.
- Knowledge Leadership: Stay current with evolving regulations and language requirements affecting ICFs and serve as a Subject Matter Expert (SME). Conduct internal training sessions when required.
- Documentation: Maintain accurate and complete records of ICF-related documents for inclusion in the Trial Master File (TMF).
- Mentorship: Provide guidance and training to new hires during their onboarding phase.
- Representation: Represent the Functional Services Area (FSA) during audits, inspections, and relevant internal committees or working groups.
- Informed Consent Specialist II at ICON plc Work from Office or Home
Candidate Profile
- Minimum 2 years of experience in Informed Consent Form (ICF) writing or development.
- Excellent English writing and communication skills.
- In-depth understanding of ICH/GCP guidelines and regional regulations governing informed consent.
- Strong analytical and problem-solving skills with keen attention to detail.
- Ability to collaborate effectively with global and cross-functional teams.
- Experience in protocol review and interpretation is desirable but not mandatory.
What ICON Offers
ICON believes that its success is built on the quality of its people. To reward performance and support overall well-being, ICON provides a comprehensive benefits package, competitive salary, and professional growth opportunities. Informed Consent Specialist II at ICON plc Work from Office or Home
Employee Benefits Include:
- Competitive annual salary structure
- Comprehensive health insurance plans for employees and families
- Generous annual leave and flexible work-life balance options
- Retirement planning benefits for long-term financial security
- Access to the Global Employee Assistance Programme (TELUS Health) for 24/7 mental health and wellness support
- Life assurance and country-specific optional benefits such as childcare vouchers, gym memberships, health assessments, and travel subsidies
Diversity, Inclusion, and Equal Opportunity
ICON plc embraces diversity and inclusion as core values. The company is dedicated to maintaining an accessible and discrimination-free workplace for all employees. Candidates are encouraged to apply regardless of background, gender, disability, or other protected characteristics. Informed Consent Specialist II at ICON plc Work from Office or Home
If you require reasonable accommodation during the recruitment process due to a medical condition or disability, ICON will provide necessary support to ensure equal access to opportunities. Informed Consent Specialist II at ICON plc Work from Office or Home
Why Join ICON plc?
By joining ICON, you become part of a globally respected organization that is shaping the future of clinical research and healthcare innovation. As an Informed Consent Specialist II, your expertise will help ensure that clinical studies are conducted ethically and that participants are fully informed, contributing directly to advancing global health outcomes. Informed Consent Specialist II at ICON plc Work from Office or Home
How to Apply
Interested candidates are encouraged to apply through the official ICON careers page.
If you are already an ICON employee, please apply through the internal application portal. Informed Consent Specialist II at ICON plc Work from Office or Home
Even if you do not meet every listed qualification, ICON encourages you to apply — you may still be the right fit for this or future roles.
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