Informed Consent Specialist (ICF) – Clinical Trials
Location: India (Bangalore, Chennai, Trivandrum)
Job Type: Full-Time | Office with Flex
Company: ICON plc
Job ID: JR146421
About the Role
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking an experienced Informed Consent Specialist (ICF) to support clinical trial start-up and regulatory processes. This role is critical in ensuring the accuracy, compliance, and timely approval of informed consent documentation, directly contributing to ethical clinical research and successful study initiation.
The position requires strong expertise in ICF development, regulatory compliance, and stakeholder collaboration within global clinical trials.
Key Responsibilities
Develop, review, and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICFs) for global, country-specific, and site-level use
Ensure compliance with ICH-GCP guidelines, ICON SOPs, and country-specific regulatory requirements
Act as a key liaison between 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)
Manage and track ICF timelines, proactively identifying risks and implementing mitigation strategies
Maintain accurate and audit-ready documentation for Trial Master File (TMF) submission
Provide subject matter expertise (SME) and support training initiatives on ICF processes and regulatory updates
Mentor and support onboarding of new team members
Represent the function during audits, inspections, and internal governance meetings
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, or a related field
4 to 8 years of experience in clinical trial Feasibility, Study Start-Up (SSU), or Site Activation
Minimum 2+ years of hands-on experience in ICF writing, review, and development
Strong understanding of ICH-GCP guidelines and informed consent regulations
Excellent English writing, documentation, and communication skills
Strong analytical and problem-solving abilities with high attention to detail
Proven ability to collaborate across global teams and stakeholders
Preferred Skills
Experience in protocol interpretation and review
Exposure to global regulatory submissions and ethics processes
Experience in mentoring or training team members
Why Join ICON
ICON offers a collaborative and inclusive work environment focused on innovation, quality, and professional growth in clinical research.
Key Benefits Include
Competitive salary and career advancement opportunities
Flexible work model (office with flexibility)
Generous leave policies
Comprehensive health insurance coverage
Retirement and financial planning benefits
Global Employee Assistance Programme (24/7 well-being support)
Life insurance and wellness initiatives
Flexible, country-specific employee benefits
Diversity, Equity & Inclusion
ICON is committed to building an inclusive workplace and is an equal opportunity employer. All qualified applicants will receive equal consideration without discrimination.
Application Note
Candidates who may not meet every requirement are encouraged to apply. ICON values diverse skills and supports continuous learning and career development.
This role is ideal for clinical research professionals specializing in informed consent documentation, regulatory compliance, and study start-up activities within global clinical trials.
Uttar Pradesh :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Peru | Argentina |Brazil :
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Tallinn |Hà Nội :
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