Job Title: Informed Consent Specialist II – Clinical Research
Location: Bangalore, Chennai, Trivandrum, Bengaluru (Remote/Office)
Job Type: Full-Time
Experience Required: Minimum 2 Years
Job ID: JR139341
ICON plc is a global leader in healthcare intelligence and clinical research, delivering innovative solutions that advance the development of life-changing therapies. We pride ourselves on fostering an inclusive environment that drives excellence and innovation in clinical development. By joining ICON, you become part of a dynamic team committed to shaping the future of clinical research while maintaining the highest ethical standards.
The Informed Consent Specialist II plays a critical role in ensuring the accuracy, compliance, and timely approval of Informed Consent Forms (ICFs) and Subject Information Sheets (SIS) across global and country-specific clinical studies. This position ensures that clinical trials adhere to regulatory requirements, ethical standards, and Good Clinical Practice (GCP) guidelines, contributing directly to the successful initiation and conduct of studies.
ICF & SIS Development: Prepare, review, and approve global master templates, country-specific, and site-specific Informed Consent Forms and Subject Information Sheets.
Regulatory Compliance: Apply thorough knowledge of ICON SOPs/WPs, ICH/GCP guidelines, and country-specific regulations to ensure ICF accuracy and compliance.
Stakeholder Collaboration: Serve as the primary point of contact for Sponsors, Study Start-Up Project Managers, Clinical Trial Managers, and functional leads to drive project success.
Query Management: Review, negotiate, and approve Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to ICFs.
Timeline Management: Track and forecast SIS/ICF approval timelines, proactively identify risks, and implement contingency plans to mitigate delays.
Knowledge Leadership: Act as a Subject Matter Expert (SME) on ICF topics, stay updated on regulatory and language changes, and deliver training sessions for team members.
Documentation & Archiving: Ensure all ICFs and related documents are accurate, complete, and appropriately filed in the Trial Master File (TMF).
Mentorship & Team Support: Coach new hires during onboarding and guide junior team members.
Audit & Inspection Support: Represent the team at audits, inspections, and internal committees, ensuring regulatory compliance and readiness.
Minimum 2 years of experience in ICF review, development, or related clinical documentation
Strong command of English writing and communication skills
Proficient knowledge of ICH/GCP guidelines and country-specific informed consent regulations
Ability to work collaboratively in a team environment and communicate effectively with global stakeholders
Strong analytical, problem-solving, and attention-to-detail skills
Protocol review and interpretation experience preferred but not mandatory
ICON is dedicated to creating a diverse, inclusive, and accessible work environment where employees can thrive. We provide competitive salaries and a range of benefits to support your well-being and professional growth, including:
Flexible annual leave policies
Comprehensive health insurance options for you and your family
Retirement planning programs
Global Employee Assistance Program (LifeWorks)
Life assurance and optional country-specific benefits, such as childcare vouchers, gym discounts, and travel subsidies
ICON values diversity and inclusion in all aspects of employment and encourages all qualified candidates to apply. We provide reasonable accommodations for applicants with medical conditions or disabilities during the recruitment process.
Informed Consent Specialist Jobs India, Clinical Research ICF Careers, ICF Review and Writing Jobs Bangalore, Chennai, Trivandrum Clinical Trials, Clinical Documentation Specialist Role, ICON Clinical Research Careers
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