Clinical Research Administrator - Wenonah, IL, United States - Oceanic Ventures

Oceanic Ventures
Oceanic Ventures
Verified Company
Wenonah, IL, United States

3 days ago

James Miller

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James Miller

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Freelance
Description

My duties

  • As a Clinical Trial Administrator, I will support Trial Managers in managing the CTSU trial team within a matrix structure.
  • I will assist in planning, managing, and monitoring timelines, costs, and scope for Trial Teams in global supply chain activities for assigned clinical trials, including complex trials such as Mega trials, adaptive trial design, digital trials, and trials outsourced to a third party (CRO). This also includes Investigator Initiated Studies (IIS), Expanded Access Programs (EAP), and Non-Product Use (NPU) programs.
  • I will support team meetings by taking minutes and noting action points and responsibilities.
  • I will assist in preparing CTS documentation.
  • I will work with various systems such as BIRDS (BI System) administration and workflows, FoCUS entries/updates, CES entries/updates, AC Evaluation coordination, AC Ordering, MLT drafting prior to TrM review/approval, GTL maintenance, manual release forms, and manual shipping requests for bulk shipments, stability samples, and sampling documentation for Investigational Medicinal Products.

My qualifications

  • I have a Bachelor's degree and relevant work experience.
  • I am willing to work onsite in the Wenonah, IL area.
  • I have experience in the pharmaceutical industry.
  • I have project management skills.
  • I have a broad and thorough understanding of applicable US and EU regulations, as well as other international regulations.
  • I am able to problemsolve
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