Clinical Trial Assistant (Contract/Freelance)

Translational Research in Oncology
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București
TRIO is a unique, full-service clinical research organization (CRO), dedicated to oncology, that leverages the strengths of our worldwide network of Investigators, academic leaders, patient advocates and our clinical research team to accelerate drug development



TRIO is looking for a Clinical Trial Assistant to join our Project Management team

This position will be remote, full-time contractor position



Responsibilities:



This position is responsible for performing any/all of the following tasks and responsibilities, as

well as any other tasks deemed appropriate by the Supervisor.

  • Provides global administrative support to the Project Management (PM) team in trial-related activities by:

    • Customizing the essential documents with trial and site-specific information.

    • Sending Global Communications.

    • Organizing and participating in meetings and writing the corresponding minutes.

    • Maintaining trial trackers.

    • Managing access requests to the trial specific systems for site staff and the PM team.

    • Assisting the Clinical Trial Manager(s) (CTM) in IRB/IEC submission and/or contract amendment(s) preparation.

    • Sending trial materials/documents to the sites.

    • Entering data in the Clinical Trial Management System (CTMS).


  • Ensures appropriate TMF maintenance by:

    • Reviewing, approving and submitting the essential documents at country/site and/or at study level (e.g. global meeting minutes, global communication) for filing in the TMF.

    • Identifying missing documents, documents expiring and other inconsistencies and following-up with the CRAs to retrieve those.

    • Performing the periodic Review of the Trial master File (TMF Quality Check (QC) at site and/or country levels including the follow-up of any detected finding until resolution.


  • Participates in the preparation of regular activity reports and might also participate in the development / review of trial specific documents, working groups (e.g. Procedures revision) involving the PM Department and CTA Mentoring program.

  • Reviews and approves invoices (e.g. sites, TPOs) according to contract specifications.

Qualifications:

  • At least one-year experience in an administrative role.

  • Knowledge in clinical research, specifically Good Clinical Practices (GCP), would be
    considered an asset.

  • Intermediate proficiency in MS Office with an advanced knowledge in Word, Excel, and
    PowerPoint.

  • Experience in clinical trials is preferred.

  • Ability to learn new systems and navigate within those systems.

  • Excellent organizational skills with a strong attention to detail.

  • Ability to work independently and to be supportive of the team’s work.

  • Excellent level of English is required, especially in written.

What TRIO Can Offer You:

  • Competitive salary

  • Paid time off

  • Flexible working hours



All interviews are currently being conducted virtually - via phone or video. We thank all candidates for their interest; only those selected for an interview will be contacted.


Innovation • Teamwork • Passion Integrity



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