Senior Study Support Assistant

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. The Role We are looking for a Senior Study Support Assistant to join our incredible team. As an integral part of the team, the below is outlined for tasks/responsibilities which the role will entail; **Responsibilities**: - Support the Study Start Up Leads including tracking, filing and - other coordinating tasks. - Assist the team with submission documentation and guidelines, - as appropriate. - Collate and verify, for completeness, submission documentation - for submission to the Regulatory/Competent Authority (CA)/Ethics - Committee (EC) and other relevant authorities. - Co-ordinate, dispatch and track submissions to CNEC and other - relevant authorities. - Assist in the translation of documents required for submission to - CNEC and other relevant authorities. - Co-ordinate the translation of documents required for - submission to CNEC and other relevant authorities. - Assist team with submission progress tracking by updating the relevant ICON/Sponsor tracking system, as required. - Set up, organize and maintain department electronic filing systems. - Assist in co-ordination of payments to CA/EC and other relevant authorities, as appropriate. - Willingness to travel for job related activities if required (expected travel for this position is < 5 %). What You Need - Minimum 3 years experience in clinical research - SSU department. - Able to provide support on EC and RA submission activities. - Able to support translation activities of study documents such as ICF, protocol, etc. - Able to support payment processing of sites and vendors. - Able to support TMF filing and QC activities, if possible Veeva Vault platform. Benefits of Working at ICON Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and 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.