CTA London, England
Job description
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.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
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.
Job Responsibilities:
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
Job-related skills
- 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)
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, 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.
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.
