Informed Consent Specialist (ICF)
Company
ICON plc – Global healthcare intelligence and clinical research organization.
Job Details
Job Title: Informed Consent Specialist (ICF)
Job Requisition ID: JR146421
Employment Type: Full-time
Work Mode: Office with Flex
Locations:
Bangalore, India
Chennai, India
Trivandrum, India
About the Role
ICON is seeking an experienced Informed Consent Specialist (ICF) to support the preparation, review, and approval of informed consent documentation for global clinical trials. The role focuses on ensuring ethical, regulatory, and operational compliance during study startup and site activation activities.
Key Responsibilities
1. Informed Consent Form Development & Review
Prepare, review, and approve:
Subject Information Sheets (SIS)
Informed Consent Forms (ICF)
Manage:
Global master templates
Country-specific versions
Site-specific adaptations
2. Regulatory & Compliance Management
Ensure compliance with:
ICON SOPs and Work Practices
ICH/GCP guidelines
Country-specific informed consent regulations
3. Stakeholder Collaboration
Act as a key contact for:
Sponsors
SSU Project Managers
Clinical Trial Managers
Cross-functional teams
Support successful project execution and performance optimization.
4. Query Management
Review, negotiate, and approve queries from:
Ethics Committees (EC)
Institutional Review Boards (IRB)
Competent Authorities (CA)
5. Timeline & Risk Management
Forecast and monitor ICF approval timelines.
Identify risks proactively and implement mitigation plans.
6. Subject Matter Expertise
Serve as SME for assigned topics.
Stay updated with evolving regulatory and language requirements.
Conduct and support training activities.
7. Documentation & TMF Support
Ensure accurate filing and archival of ICF documents within the Trial Master File (TMF).
8. Mentorship & Team Support
Mentor and coach new hires during onboarding.
9. Audit & Inspection Support
Represent the department during:
Audits
Inspections
Internal committees and workgroups
Required Qualifications
Experience
4–8 years of experience in:
Feasibility
Study Start-Up
Site Activation
Minimum 2 years of hands-on experience in ICF writing/development is mandatory.
Skills & Knowledge
Strong English writing and communication skills.
Good understanding of:
ICH/GCP guidelines
Country-specific informed consent regulations
Strong analytical and problem-solving abilities.
Excellent attention to detail.
Ability to collaborate effectively with diverse stakeholders.
Preferred
Experience in protocol interpretation and review is preferred but not mandatory.
Benefits & Rewards
ICON offers a comprehensive rewards package that may include:
Competitive salary and performance incentives
Medical, dental, and vision coverage
Retirement and pension plans
Life and disability insurance
Employee assistance programs
Learning and career development opportunities
Benefits may vary based on role and location.
Inclusion & Accessibility
ICON is an equal opportunity employer committed to building an inclusive and accessible workplace.
Reasonable accommodations during recruitment are available upon request.
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