Informed Consent Specialist II
Locations: Bangalore | Chennai | Trivandrum | Bengaluru
Job ID: JR139341
Department: Study Start-Up, ICON Full Service & Corporate Support
Work Model: Office-Based or Home-Based (as applicable)
About the Role
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking an experienced Informed Consent Specialist II. This role is essential to the ethical and compliant execution of clinical trials across multiple regions. The Specialist will be responsible for developing, reviewing, and managing informed consent documentation to ensure regulatory adherence and timely study start-up.
This position requires strong technical expertise in ICF development, regulatory understanding, and cross-functional collaboration. Candidates will contribute directly to efficient study initiation and high-quality clinical operations.
Key Responsibilities
Informed Consent Development and Review
Prepare, review, and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global master templates, country-specific versions, and site-level adaptations.
Ensure accuracy, clarity, and compliance across all informed consent documents.
Regulatory and Compliance Oversight
Apply in-depth knowledge of ICON SOPs/WPs, ICH-GCP guidelines, and regional regulatory requirements for informed consent.
Ensure consistent adherence to compliance standards across all submitted documents.
Cross-Functional Collaboration
Act as a primary liaison for Sponsors, Study Start-Up Project Managers, Clinical Trial Managers, and key functional stakeholders.
Support seamless project execution through proactive communication and coordination.
Handling Ethics and Regulatory Queries
Review, negotiate, and approve Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) responses related to ICF documents.
Address complex query resolutions within expected timelines.
Timeline and Risk Management
Forecast and track ICF approval timelines.
Identify potential delays early and implement contingency plans to ensure consistent study progress.
Subject Matter Expertise and Training
Serve as a Subject Matter Expert (SME) for informed consent processes, regulatory updates, and language requirements.
Provide training and knowledge sharing across teams.
Documentation and TMF Compliance
Ensure accurate transfer, filing, and archiving of ICF documents within the Trial Master File (TMF).
Mentorship and Representation
Mentor new hires during onboarding.
Represent the Functional Service Area team during audits, inspections, committees, and workgroups.
Experience Required
Minimum 2 years of hands-on experience in informed consent form (ICF) writing, development, or review within clinical research.
Strong command of written English with proven ability to draft regulatory and study-related documents.
Thorough understanding of ICH-GCP guidelines and regional regulatory frameworks related to informed consent.
Experience in interpreting clinical protocols is preferred but not mandatory.
Demonstrated ability to work collaboratively with global stakeholders.
Strong analytical, organizational, and decision-making skills with high attention to detail.
What ICON Offers
ICON is committed to fostering a diverse, high-performance culture that promotes continuous learning, career growth, and employee well-being.
Benefits may include:
Competitive salary and country-specific annual leave
Comprehensive health insurance options
Retirement planning and financial wellness support
Global Employee Assistance Program (LifeWorks)
Life assurance and additional local flexible benefits such as childcare vouchers, gym discounts, subsidized travel, and wellness programs
For country-specific benefit details, visit the ICON careers site.
Inclusion and Equal Opportunity
ICON is dedicated to creating an inclusive and accessible work environment. All qualified applicants will receive equal consideration without regard to race, gender, identity, nationality, disability, or protected veteran status.
If you require accommodation during the application process due to a medical condition or disability, please submit a request through the designated support channel.
Apply Now
If you are motivated to support ethical clinical research and meet the qualifications, we encourage you to apply. Even if you do not meet every requirement, ICON welcomes your application as your skillset may align with this or future opportunities.
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