Location: Bangalore / Chennai / Trivandrum, India (Office with Flex)
Company: ICON plc
Job ID: JR146421
Employment Type: Full-Time
Experience Required: 4–8 Years (Not suitable for freshers)
About the Company
ICON plc is a globally recognized healthcare intelligence and clinical research organization delivering excellence across the drug development lifecycle. With a strong focus on innovation, compliance, and patient-centric research, ICON supports global sponsors in advancing clinical trials efficiently and ethically.
Job Overview
The Informed Consent Specialist (ICF Specialist) is responsible for the creation, review, and approval of informed consent documents across global clinical trials. This role plays a critical part in ensuring ethical compliance, regulatory adherence, and timely study start-up by managing Subject Information Sheets (SIS) and Informed Consent Forms (ICF).
Key Responsibilities
Develop, review, and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICF) including global templates, country-specific, and site-specific versions
Ensure compliance with ICH-GCP guidelines, regulatory requirements, and internal SOPs related to informed consent processes
Act as a central point of contact for Sponsors, SSU Project Managers, Clinical Trial Managers, and cross-functional teams
Review, negotiate, and resolve queries from Ethics Committees (EC), Institutional Review Boards (IRB), and Competent Authorities (CA)
Track and manage ICF approval timelines, proactively identifying risks and implementing mitigation strategies
Maintain high-quality documentation and ensure accurate filing within the Trial Master File (TMF)
Provide subject matter expertise (SME) support and conduct training on ICF-related processes and regulatory updates
Mentor and support onboarding of new team members
Represent the department during audits, inspections, and cross-functional meetings
Required Qualifications
4 to 8 years of experience in Feasibility, Study Start-Up (SSU), or Site Activation within clinical research
Minimum 2 years of hands-on experience in ICF writing, review, or development
Strong understanding of ICH-GCP guidelines and country-specific regulatory requirements for informed consent
Excellent English writing, documentation, and communication skills
Strong analytical mindset with high attention to detail
Ability to collaborate effectively with global stakeholders and cross-functional teams
Experience in protocol interpretation and clinical document review is an added advantage
Why This Role Matters
This role directly contributes to ethical clinical trial conduct by ensuring patients are fully informed and protected. As an ICF Specialist, you are positioned at the intersection of compliance, patient safety, and global research operations.
Compensation and Benefits
Competitive salary aligned with industry standards
Comprehensive health insurance plans for employees and families
Retirement and long-term financial planning benefits
Global Employee Assistance Program supporting mental health and well-being
Flexible benefits including childcare support, wellness programs, and travel subsidies
Paid leave and work-life balance initiatives
Diversity and Inclusion Commitment
ICON plc fosters an inclusive and equitable work environment. All qualified candidates are considered without discrimination based on race, gender, disability, or any protected status.
Important Note for Applicants
This position requires prior experience in informed consent documentation and clinical trial start-up activities. Freshers are advised to apply for entry-level roles such as Clinical Trial Assistant (CTA), Clinical Research Coordinator (CRC), or Regulatory Associate to build foundational experience.
How to Apply
Apply directly through the official careers page of ICON plc or explore verified global clinical research jobs on ThePharmaDaily.com
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Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
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Zaventem |South America :
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