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

We are looking candidate located in Romania Bukarest

Description of Roles and Responsibilities

• Trial and site administration:

o Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
o Ensure collation and distribution of study tools and documents
o Update clinical trial databases (CTMS) and trackers
o Clinical supply & non-clinical supply management, in collaboration with other
country roles
o Manage Labeling requirements and coordinate/sign translation change request

• Document management:

o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents
o Assist with e TMF reconciliation
o Updating manuals/documents (e.g., patient diaries, instructions)
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
o Execute e TMF Quality Control Plan
o Obtain translations of documents

• Regulatory & Site Start-Up responsibilities:

o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
o Obtain, track and update study insurance certificates
o Support preparation of submission package for IRB/ERC and support regulatory
agencies submissions.
o Publish study results for GCTO and RA where required per local legislation

• Budgeting, Agreement and Payments: Collaborate with finance/budgeting

representatives for:
o Develop country and site budgets (including Split site budget)
o Tracking, and reporting of negotiations
o Maintenance of tracking tools
o Contract development, negotiation, approval and maintenance (e.g. CTRAs)
o Update and maintain contract templates (in cooperation with Legal Department)
o Payment calculation and execution (investigators, vendors, grants)
o Ensure compliance with financial procedures
o Monitor and track adherence and disclosures,
o Budget closeout.

• Meeting Planning:

o Organize meetings (create & track study memos/letters/protocols)
o Support local investigator meetings (invitations, prepare materials, select venue,

Minimum 1-2 years in Clinical Research or relevant healthcare experience
Note - Specific experience requirements may vary depending on the Country

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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:

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.