Job
Description
Informed Consent Specialist II - Office or Home - India ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Were currently seeking an Informed Consent Form (ICF) Specialist to join our diverse and dynamic team. As an ICF Specialist at ICON, youll be crucial in ensuring the accuracy, compliance, and timely approval of informed consent forms for clinical trials. Your role will directly contribute to the ethical conduct of clinical research and the successful initiation of studies. What youll be doing: Developing and reviewing ICFs: Preparing, reviewing, and approving Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global master templates, country-specific versions, and site-specific adaptations. Ensuring compliance: Applying proficient knowledge of ICON SOPs/WPs, ICH/GCP guidelines, and applicable country regulations related to Informed Consent requirements. Stakeholder collaboration: Serving as a key point of contact for Sponsors, SSU Project Managers, Clinical Trial Managers, and other functional leads to optimize performance and ensure successful project outcomes. Query resolution: Proficiently reviewing, negotiating, and approving all Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to country and site-specific ICFs. Timeline management: Forecasting and tracking SIS & ICF approval timelines, proactively identifying risks, and developing contingency plans to mitigate potential impacts. Knowledge leadership: Acting as a Subject Matter Expert (SME) for assigned topics, staying updated on changing regulatory and language requirements affecting ICFs, and developing/conducting training. Documentation and archiving: Ensuring the accuracy and completeness of ICF documents transferred for filing into the Trial Master File (TMF). Mentorship: Mentoring and coaching new hires during their onboarding process. Representing FSA: Representing the department at audits, inspections, and on various committees and work groups. Your profile: Minimum 2 years of experience in ICF writing/development. Strong English writing and and communication skills are required. Proficient knowledge of ICH/GCP guidelines and applicable country regulations related to Informed Consent. Ability to work collaboratively in a team environment and effectively communicate with diverse stakeholders. Strong analytical and problem-solving skills, with excellent attention to detail. Protocol interpreting & review is preferred, but not required.
