ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing medical science through innovative clinical trials. With a commitment to excellence, diversity, and inclusion, ICON fosters a collaborative environment where professionals can thrive and contribute to groundbreaking research.
Job Description: Informed Consent Specialist II
Key Responsibilities:
- Develop & Review ICFs: Prepare, review, and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global, country-specific, and site-level use in clinical trials.
- Ensure Compliance: Apply knowledge of ICH/GCP guidelines, ICON SOPs, and country-specific regulations to maintain ethical and legal standards.
- Stakeholder Collaboration: Work closely with Sponsors, SSU Project Managers, Clinical Trial Managers, and other teams to ensure smooth study initiation.
- Query Resolution: Address and negotiate Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to ICFs.
- Timeline Management: Track SIS & ICF approval timelines, identify risks, and implement contingency plans.
- Knowledge Leadership: Serve as a Subject Matter Expert (SME), staying updated on regulatory changes and conducting training sessions.
- Documentation & Archiving: Ensure accurate filing of ICF documents in the Trial Master File (TMF).
- Mentorship: Guide and train new hires during onboarding.
- Audits & Inspections: Represent the department in audits, inspections, and regulatory meetings.
Qualifications & Skills:
- Minimum 2 years of experience in ICF writing/development.
- Strong English writing & communication skills.
- Knowledge of ICH/GCP guidelines and country-specific regulatory requirements.
- Ability to interpret & review clinical trial protocols (preferred).
- Analytical mindset, attention to detail, and problem-solving skills.
Why Join ICON?
ICON offers a competitive salary and comprehensive benefits, including:
✅ Flexible annual leave
✅ Health insurance for you & your family
✅ Retirement planning support
✅ Global Employee Assistance Programme (TELUS Health)
✅ Life assurance
✅ Country-specific perks (childcare vouchers, gym discounts, travel passes, etc.)
ICON is an equal opportunity employer, committed to diversity and inclusion. We encourage all qualified candidates to apply, even if they don’t meet every requirement.
