Informed Consent Specialist II

ICON plc • Charlotte, NC

11d

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. 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.

Requirements

• 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.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Responsibilities

• Leading the creation, review, and optimisation 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 standardisation and efficiency.
• Providing training and mentorship to junior team members on informed consent principles, processes, and quality standards.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level