* Maintain up to date participating center's information (including all contact details, contracts and reports).
* Responsible for preparing the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical Assist Sponsor study staff with maintaining the sponsor files during the life of the study.
* Responsible for archiving at the end of study in accordance with relevant client's SOPs, policies and local regulatory requirements.
* Input and oversee Sponsor clinical study tracking systems
* Proactively identifies issues and raises them to the client study staff to take necessary corrective action to ensure smooth and rapid progress of studies
* Assist in the planning, logistics and preparation of local Investigator meetings (travel arrangements, assist with preparation and distribution of study related presentation material )
* Responsible for working with the Sponsor Study staff for the management of study materials, non-IMP and IMP supplies - distribution, ordering, tracking, storage, reconciliation and destruction using external vendor. Details of destruction to be filed.
* As an active participant of clinical study teams, engage in local study meetings during the life of the study to obtain general knowledge about the study and be responsible for given Assist Sponsor study staff with study related activities such as:
* organizing study meetings and scheduling travel,
* producing minutes for study-related meetings,
* assembling training and study materials,
* updating contact details,
* maintaining study documentation,
* assisting in the preparation of documents and other tasks as
* Knowledgeable of Sponsor systems
* Keep up to date with all the changes/required knowledge on ICH GCP, Client written standards and attending appropriate training
* May be responsible for supporting multiple studies simultaneously and must prioritize appropriately to meet business needs to ensure delivery of results
* Requirement to communicate and work effectively with medical staff/physicians/scientists who are often senior within their field, being mindful of their standing within the medical and/or research
Excellent technical/IT skills
* Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of Sponsor systems/software
* Knowledge of relevant operational procedures, systems and quality guidelines regarding clinical studies
* At least 10 months' experience working as a Clinical Trial Assistant/Associate
* Able to work independently as well as in a Team
* Professional attitude with good customer focus (internal and external)
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
Working fully embedded within one of our multinational pharmaceutical clients, with the support of ICON right behind you, you'll be at the heart of our client's innovation. As a Clinical Trial Assistant, you will be dedicated to one of our global pharmaceutical clients who's focus is on serious chronic diseases that affect hundreds of millions of people and are among the most urgent global health challenges. In this role you will be doing local affiliate study set-up in the CTMS system, providing some admin for the Regulatory and Ethics submissions team and track shipments and paperwork for our sponsor's local depot., As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond. ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world's leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact. Why choose a career with ICON Strategic Solutions? Meaningful Work: You'll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives. Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally. Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently. Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization. Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.
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 maximise 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