Clinical Study Assistant

As a Clinical Study Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Clinical Study Assistant (CSA) assists in the coordination and administration of the study activities in Romania from the start up to execution and close out, and within the Local Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. 

In this role you will work 4 days per week in the sponsor's office in Bucharest.

Responsisbilities:

• Collects, assists in preparation, reviews and tracks documents for the application process.
• Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
• Interfaces with Investigators, external service providers and CRAs during the document Local Study Manager for the duration of the study.
• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements
• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System ensuring compliance with the sponsor's  Authoring Guide for Regulatory Documents.
• Sets-up, populates and accurately maintains information in tracking and communication tools (e.g. CTMS, SharePoint, etc) and supports others in the usage of these systems
• Prepares and/or supports contract preparation at a site level
• Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
• Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaises with internal and external participants and/or vendors, in line with international and local codes.
• Prepares, contributes to and distributes presentation material for meetings, newsletters and websites.
• Responsible for layout and language control, copying and distribution of documents. Supports with local translation and spell checks in English to/from local language, as required.
• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails.

Requirements:

• Bachelor’s Degree or international equivalent in business, finance, health sciences or related field
• A minimum of 6 months' previous experience  as a CTA, Clinical Project Assistant or in a similar role providing administrative support to the local clinical trial operations
• Read write and speak fluent English; fluent in Romania required.
• Ability to work in the sponsor's office 4 days a week in Bucharest

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.

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