Overview
Role: Clinical Trial Assistant
Location: Gatwick (homeworking offered, 2-3 days per week)
Sponsor dedicated
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.
Responsibilities
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 whose 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:
1. Maintain up to date participating center's information (including all contact details, contracts and reports).
2. Responsible for preparing the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical trials.
3. Assist Sponsor study staff with maintaining the sponsor files during the life of the study.
4. Responsible for archiving at the end of study in accordance with relevant client's SOPs, policies and local regulatory requirements.
5. Input and oversee Sponsor clinical study tracking systems.
6. Proactively identifies issues and raises them to the client study staff to take necessary corrective action to ensure smooth and rapid progress of studies.
7. Assist in the planning, logistics and preparation of local Investigator meetings (travel arrangements, assist with preparation and distribution of study related presentation material).
8. 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.
9. 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.
10. Responsible for organizing study meetings and scheduling travel.
11. Producing minutes for study-related meetings.
12. Assembling training and study materials.
13. Updating contact details and maintaining study documentation.
14. Assisting in the preparation of documents and other tasks as required.
15. Knowledgeable of Sponsor systems.
16. Keep up to date with all the changes/required knowledge on ICH GCP, Client written standards and attending appropriate training.
17. May be responsible for supporting multiple studies simultaneously and must prioritize appropriately to meet business needs to ensure delivery of results.
18. Requirement to communicate and work effectively with medical staff/physicians/scientists who are often senior within their field.
Qualifications
You are:
1. Excellent technical/IT skills.
2. Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of Sponsor systems/software.
3. Knowledge of relevant operational procedures, systems and quality guidelines regarding clinical studies.
4. At least 10 months' experience working as a Clinical Trial Assistant/Associate.
5. Able to work independently as well as in a Team.
6. Professional attitude with good customer focus (internal and external).
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 designed to be competitive within each country and 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.
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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 through the form below: https://careers.iconplc.com/reasonable-accommodations
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.
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