Informed Consent Specialist ICF review and creation experience is required 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 We re currently seeking an Informed Consent Form ICF Specialist to join our diverse and dynamic team As an ICF Specialist at ICON you ll 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 you ll 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 workplace 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 LI-KT1 What ICON can offer you Our success depends on the quality of our people That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent In addition to your competitive salary ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family Our benefits examples include 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 Visit our careers site to read more about the benefits ICON offers At ICON inclusion belonging are fundamental to our culture and values We re dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or protected veteran status If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please let us know Interested in the role but unsure if you meet all of the requirements We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles

📌 Informed Consent Specialist Ii (Karnataka)
🏢 ICON
📍 Karnataka