Informed Consent Specialist II – ICON plc (Bangalore, Chennai, Trivandrum)
Job Summary:
ICON plc, a global leader in healthcare intelligence and clinical research, is hiring an Informed Consent Specialist II in India (Bangalore, Chennai, or Trivandrum). This full-time role is ideal for professionals with at least 2 years of ICF writing or review experience, strong regulatory knowledge, and a passion for ethical clinical trial conduct. You will support global study start-up processes by ensuring informed consent documentation is accurate, compliant, and approved on time.
Key Responsibilities:
Develop and review Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global, country, and site-specific versions
Ensure all documentation complies with ICON SOPs, ICH-GCP, and country-specific regulations
Serve as a main contact for Sponsors, SSU Project Managers, and Clinical Trial Managers
Respond to and resolve queries from Ethics Committees (EC), Institutional Review Boards (IRB), and Competent Authorities (CA)
Track ICF approval timelines and proactively identify risks or delays
Act as Subject Matter Expert (SME) on ICF-related regulations and updates
Train and mentor new team members and represent the department in audits and meetings
Archive finalized ICFs to the Trial Master File (TMF)
Required Skills & Qualifications:
Minimum 2 years of experience in ICF writing, review, or development
Strong command of English with excellent writing and communication skills
Proficient understanding of ICH-GCP guidelines and local informed consent regulations
Ability to interpret clinical protocols and collaborate across teams
Detail-oriented with strong problem-solving and organizational skills
Prior experience with global regulatory submissions is an advantage
Perks & Benefits:
Competitive salary (not disclosed, but includes full compensation package)
Flexible leave entitlements and paid time off
Health insurance plans for individuals and families
Retirement savings options and life assurance
Global Employee Assistance Programme (LifeWorks)
Country-specific perks: gym discounts, bike purchase programs, subsidized travel, childcare vouchers, and more
Inclusive and non-discriminatory work culture
About ICON plc:
ICON plc is a top-tier clinical research organization operating in over 40 countries, offering healthcare intelligence and global support for drug development. ICON drives excellence in clinical operations, regulatory affairs, and patient safety through innovation and inclusivity.
Work Mode: Hybrid (Home or Office – India)
Call to Action:
If you're ready to advance your career in clinical research documentation and regulatory compliance, apply now for the Informed Consent Specialist II role at ICON and be part of shaping the future of healthcare.
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