Clinical Trial Assistant (East Coast)

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.

What you will be doing:

• Work on Clinical Trials by assisting the Clinical Trial Manager(s) (CTM) with the conduct of the assigned clinical trial(s) (eg administration, coordination, and archiving)
• Assist with the inspection readiness of the Electronic Clinical Operations system (ECO) for their assigned trials
• Provide support to the Clinical Trial Team (CTT) (eg ECO support, training matrix, minute taking, and/or creation of trackers, system access management)
• Help the Global Head of Trial Operations with the logistics of the departmental meetings (eg minute taking)
• Assist the Clinical Operations Lead (COL) with organizing the Clinical Team (CT) Meetings (agenda, meeting minutes, follow-up on action items)
• Support projects related to improvement/implementation of clinical processes and systems based on relevant experience
• Support onboarding of new CTAs
• Coordinate the filing of argenx Trial Master File (TMF) documents in the (electronic) Trial Master File (TMF) part of ECO by reviewing completeness and correct use of ECO. Follow-up with the CTT on findings and provide support on how to use ECO.
• Act as Business Administrator in the eTMF system, by maintaining records and supporting close-out activities (including archival preparation) in the eTMF system. This includes: managing study records, country records and site records.
• Assist the CTM/COL to ensure that the argenx Trial Operations TMF Documents are properly filed and made ready for archiving.
• Provide logistical support to the CTT on vendor (e)TMF oversight activities

You are:

• Bachelor’s degree or University degree – medical, para-medical, or equivalent by experience
• Experience supporting global client
• Knowledge of International Conference on Harmonisation- Good Clinical Practice (ICH-GCP)
• Knowledge of Drug Information Association Trial Master File (DIA TMF) reference model
• Proficient in software applications such as Outlook, Word, Excel and PowerPoint
• Experience with tools and systems for managing clinical trials such as Microsoft Project
• Experience with trial progress and metric systems (eg Electronic Case Report Form (eCRF), Interactive Response Technology (IRT), Interactive Voice/Web Response System (IXRS), and Veeva Vault)

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 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

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, colour, 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 or submit a request here.

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.