Clinical Research Associate

Organization
Cepheid - US
Job Location
Sunnyvale, CA 94089
Job Description

As a Clinical Research Associate, you will help design, plan and implement the overall direction of clinical research projects. Your primary responsibility will be to assist the study team with all operational activities for new infectious disease diagnostic test products under clinical evaluation.

 

 

  • Independently be responsible for all activities of the clinical trial including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation.
  • Devise and write study protocols, investigator manuals, site specific instruction manuals and design case report forms for new and modified products.
  • Assist in the preparation of clinical reports and clinical/non-clinical sections of regulatory submissions and prepare scientific abstracts, posters and publications arising from the trials.
  • Assist with the management of key study parameters (i.e. start-up activities, enrollment, data collection, etc.).
  • Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.

 

Requirements
  • Bachelor’s degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent.
  • Minimum of 2 years experience with In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics.
  • Previous hands-on experience in clinical research at either a pharmaceutical/biotech company or hospital is highly desirable.
  • Excellent knowledge of good clinical trial design, including the number and types of subjects and specimens that will be required, the conditions under which specimens must be collected, potential interferants for a given disease, and the current gold standard for the diagnosis of that disease.
  • Requires experience in monitoring sites and excellent team skills.
  • Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials.
  • Must also know who the thought leaders are for a given disease condition and the institutions with access to the required study populations. Knowledge of GCP & ICH guidelines and FDA regulations.
  • This is an in-house based position with traveling of 30-50%.

 

How to Apply

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