Clinical Operations - Magnolia, KY, United States - Aurora Solutions

Aurora Solutions
Aurora Solutions
Verified Company
Magnolia, KY, United States

2 days ago

James Miller

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James Miller

beBee Recruiter
Freelance
Description

As a Project Assistant (m/f/d), you will support our Clinical Operations department in a variety of ways in the execution and implementation of clinical trials.

You will use your dedication and professionalism to successfully plan and conduct clinical drug trials in phases I-IV, non-interventional studies, and medical device trials.


What you will do with us:

  • Support in organizing the study at the study centers and assisting the investigators
  • Querying the study progress at the study centers (according to a given guideline) and documenting it
  • Training investigators and documenters on the study and EDC software
  • Feasibility assessment for new projects with study centers
  • Support in creating study documents including shipping and tracking
  • Preparation of documents for submission to authorities and ethics committees
  • Creation and management of the Study Master File
  • Support for study centers in handling inquiries about electronically captured study data
  • Correspondence (according to template or own concept in German and English)
  • Shipping and tracking of documents and study materials to study centers
  • Creation/editing of study contracts (according to specifications)
  • Preparation of documents for the remuneration of study centers
  • Organization of investigator meetings
  • Creation of presentations, diagrams, and tables (independently and according to specifications)
  • Support for project support

Who you are:

  • You have successfully completed training in the medical or commercial field
  • You ideally have experience in organizing clinical trials
  • You work independently, analytically, and have
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