Clinical Research Associate

Vor 3 Tagen

Zug, Zug, Schweiz Talentor Switzerland Vollzeit

Start date: ASAP


Duration: 1 year



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, Good Clinical Practices, IVD directives, policies and procedures


Requirements:

  • Bachelor's degree in science or relevant field, Medical technology degree preferred, but not required if R&D background is adequate
  • •Preferably experience in clinical research or laboratory research
  • Min. 2 years of prior relevant experience
  • Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
    • Excellent oral and written communication skills in English
  • Good therapeutic and protocol knowledge.

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