Job Title: Informed Consent Specialist II
Company: ICON Clinical Research
Location: Bangalore, India / Beijing, China
Employment Type: Full-time
Work Mode: Office or Home (Hybrid/Flexible)
Department: Clinical Operations / Regulatory & Ethics
Experience Required: 3–7 years of experience in Clinical Research, Regulatory Affairs, Ethics, or Informed Consent Management with experience handling clinical trial documentation and participant consent processes.
Education: Bachelor’s degree in Life Sciences, Healthcare, Legal Studies, Pharmacy, Biotechnology, or a related field. Advanced degree preferred.
Salary Package: ₹10–18 LPA (Estimated as per current market standards for Informed Consent Specialist II roles in India; final compensation depends on experience, clinical research expertise, and interview performance.)
Key Responsibilities:
Lead the development, review, and optimization of Informed Consent Forms (ICFs) for global and local clinical trials.
Ensure informed consent documents comply with:
Clinical trial protocols
Sponsor requirements
Regulatory guidelines
Ethical standards
Provide expert guidance on informed consent strategy and country-specific requirements.
Review complex or high-risk study consent materials.
Manage translation processes, document version control, and consent documentation tracking.
Ensure consistency and traceability of consent materials across global regions.
Collaborate with:
Sponsors
Ethics Committees (IRB/IEC)
Regulatory Authorities
Clinical Study Teams
Address regulatory and ethics-related queries related to consent documents.
Develop templates, guidance documents, and best practices for informed consent processes.
Train and mentor junior team members on informed consent standards and procedures.
Required Skills:
Informed Consent Form (ICF) Management
Clinical Trial Documentation
Clinical Research Regulations
GCP Guidelines
Ethics Committee / IRB / IEC Requirements
Regulatory Compliance
Patient-Friendly Medical Writing
Document Review & Editing
Version Control Management
Stakeholder Management
Cross-functional Collaboration
Communication Skills
Quality Management
Preferred Skills:
Experience working on global clinical trials.
Knowledge of international informed consent regulations.
Experience with sponsor and regulatory interactions.
Strong understanding of participant protection principles.
Experience managing multiple studies simultaneously.
Medical writing or regulatory writing experience is an advantage.
Work Locations:
Bangalore, India
Beijing, China
Benefits:
Competitive salary and performance incentives.
Health and wellness programs.
Medical, insurance, and retirement benefits (as applicable).
Learning and development opportunities.
Career growth pathways within clinical research.
Opportunity to support global clinical trials and patient-focused research.
Inclusive and collaborative work environment.
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