Informed Consent Specialist (ICF Review and Creation)
Job Locations: Bangalore, Chennai, or Trivandrum, India
Work Model: Office-Based or Home-Based
Job Type: Full-Time
Job Requisition ID: JR139341
Industry: Clinical Research / Regulatory Affairs / Study Start-Up
The Informed Consent Specialist is a critical clinical research role responsible for the development, review, compliance validation, and approval management of Subject Information Sheets (SIS) and Informed Consent Forms (ICFs) across global clinical trials. This position ensures ethical, regulatory, and operational alignment of informed consent documentation in accordance with ICH-GCP guidelines and country-specific regulatory requirements.
This opportunity is ideal for professionals with hands-on ICF writing and review experience who want to contribute directly to ethical clinical trial conduct and global study activation.
Role Overview
The Informed Consent Specialist supports global and regional clinical studies by creating, reviewing, negotiating, and approving informed consent documents. The role ensures documents are compliant, linguistically accurate, ethically sound, and aligned with protocol requirements.
The position requires close collaboration with Sponsors, Study Start-Up teams, Clinical Trial Managers, and regulatory stakeholders to ensure timely approvals and inspection readiness.
Key Responsibilities
Develop, review, and approve global master ICF templates, country-specific ICFs, and site-specific adaptations
Prepare and review Subject Information Sheets (SIS) ensuring clarity, regulatory accuracy, and patient comprehension
Apply strong knowledge of ICH-GCP, SOPs, and country-level informed consent regulations
Review, negotiate, and respond to Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to ICF documentation
Forecast and track ICF and SIS approval timelines to ensure study start-up milestones are achieved
Proactively identify risks impacting ICF approvals and implement mitigation strategies
Ensure accurate documentation and transfer of final ICF versions to the Trial Master File (TMF)
Act as a Subject Matter Expert (SME) for ICF processes, regulatory updates, and language requirements
Develop and deliver training sessions related to informed consent best practices
Mentor and support new team members during onboarding
Represent the department during audits, inspections, and cross-functional meetings
Required Experience
Minimum 2 years of hands-on experience in ICF writing, development, and regulatory review
Experience in global clinical trial documentation is preferred
Exposure to study start-up activities and regulatory submissions is advantageous
Protocol interpretation and review experience preferred but not mandatory
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related field
Advanced degree preferred
Core Skills and Competencies
Strong English writing, editing, and communication skills
In-depth understanding of ICH-GCP guidelines and country-specific informed consent regulations
Excellent analytical skills and attention to detail
Strong stakeholder management and cross-functional collaboration abilities
Ability to manage multiple projects and meet strict timelines
Knowledge of TMF documentation standards
Problem-solving skills with a compliance-focused mindset
Why Apply Through ThePharmaDaily.com
ThePharmaDaily.com connects clinical research professionals with leading global CROs, pharmaceutical companies, and biotech organizations. If you have expertise in ICF development, regulatory compliance, and clinical documentation, this position offers strong career progression in Study Start-Up and Clinical Operations.
Apply now to advance your career in Informed Consent Management and Clinical Trial Compliance.
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Frank Scottile Blvd |Missouri :
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Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Uxbridge | Australia | Richmond Hill | Mississauga | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
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Koropi | Athens |Greece :
Greece |North Island :
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Austria |Vienna :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
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Tallinn |Hà Nội :
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