Clinical Research Associate

vor 2 Wochen

Rotkreuz, Zug, Schweiz Coopers Group AG Vollzeit CHF 90'000 - CHF 120'000 pro Jahr

Contract duration: 1 year/possible extension

Travel: 20% in Europe

Workload: 100%

The Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.

Responsibilities:

  • Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements
  • Validating product performance claims
  • Supplying data for critical Regulatory submissions
  • Defining the functional and clinical utility of investigational products
  • Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders
  • The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions
  • Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout
  • Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met
  • Interfacing with cross functional staff to support post launch activities
  • Reviewing cases with investigators to resolve discrepancies
  • Ensuring that studies adhere to FDA regulations and Good Clinical Practices

Requirements:

  • Degree in science or relevant field, Medical technology degree preferred, but not required if R&D background is adequate
  • Willing to travel 20% of the time in Europe
  • Experience in clinical research and working in laboratory
  • Knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)

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