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Informed Consent Specialist Ii

2+ years
Not Disclosed
10 July 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.