Clinical Research Specialist

2 days ago


Mounds View, United States Redbock - an NES Fircroft company Full time

**CANDIDATES CURRNETLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLY**


Clinical Research Specialist (24 month contract // Mounds View, MN):

HM's Top 3:

  1. Site Management experience (site or sponsor)
  2. Knowledge of/experience with CTMS/EDC/TMF
  3. Experience with Good Clinical Practice (GCP)


Description:

In this exciting role as a Clinical Research Specialist, you will have primary focus responsibility in preparing sites for data collection, relationship building with research coordinators, regulatory report writing, and data cleaning. The CRS works under the direction of a Clinical Study Manager and assists with numerous tasks associated with the execution of a clinical trial.


The Study & Scientific Solutions (S&SS) is a function within our client’s Core Clinical Solutions. S&SS is an internal service provider to all of the client’s business units and assigns resources to assist them execute on clinical trials and scientific projects when they have an increase in workload.


Duties:

  • Oversees, designs, plans, and develops clinical evaluation research studies.
  • Prepares and authors protocols and patient record forms.
  • Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
  • Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.
  • May be responsible for clinical supply operations, site and vendor selection.


Required Knowledge and Experience:

  • Education Required: Bachelor Degree (prefer degree in engineering, life sciences, or related medical/scientific field.)
  • Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 1 years of experience.


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