[Hiring] Informed Consent Specialist II @ICON plc

Role Description

As an Informed Consent Specialist II at ICON, you will take a lead role in the development, review, and oversight of informed consent documents for complex, global clinical trials.

Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders.

• Leading the creation, review, and optimization of global and local informed consent forms (ICFs) in alignment with protocol, regulatory, and sponsor requirements.
• Advising study teams on informed consent strategy, content, and country-specific considerations, including complex or high-risk studies.
• Overseeing translation processes, version control, and documentation to ensure consistency and traceability across regions.
• Interfacing with sponsors, ethics committees, and regulatory bodies to address queries and negotiate consent wording when required.
• Developing and maintaining guidance, templates, and best practices to drive standardization and efficiency.
• Providing training and mentorship to junior team members on informed consent principles, processes, and quality standards.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Significant experience in clinical research, regulatory affairs, ethics, or a related function with a strong focus on informed consent.
• In-depth knowledge of GCP, ethical guidelines, and global regulatory expectations relating to participant information and consent.
• Excellent writing and editing skills, with the ability to convey complex information in clear, patient-friendly language.
• Strong stakeholder management and communication skills, with experience collaborating across functions and with external parties.
• Proven ability to manage multiple studies and priorities, with a high level of accuracy, accountability, and initiative.

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.