Research/Ag Specialist

University of Nebraska Medical CenterOmaha, NE
Onsite

About The Position

To assist in study evaluation, feasibility, startup, activation, and coordination of gene and cellular therapy trials to be conducted by University of Nebraska Medical Center (UNMC) and/or Nebraska Medicine (NM) investigators. This individual will be responsible for the initial feasibility of all gene and cellular therapy trials conducted within the institution, project management through the site initiation visit, and a coordination resource for gene and cellular therapy trials from activation through close-out. This individual will be responsible for liaising with the sponsor and Nebraska Medicine staff to ensure FDA (Food and Drug Administration) and sponsor requirements are met for activating and coordinating gene and cellular therapy expanded access to protocols. This person will help maintain good clinical practices involving gene and cellular therapy research protocols.

Requirements

  • 3 years of experience

Responsibilities

  • Assist in study evaluation, feasibility, startup, activation, and coordination of gene and cellular therapy trials.
  • Responsible for the initial feasibility of all gene and cellular therapy trials conducted within the institution.
  • Responsible for project management through the site initiation visit.
  • Serve as a coordination resource for gene and cellular therapy trials from activation through close-out.
  • Liaise with the sponsor and Nebraska Medicine staff to ensure FDA and sponsor requirements are met for activating and coordinating gene and cellular therapy expanded access to protocols.
  • Help maintain good clinical practices involving gene and cellular therapy research protocols.
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