Clinical Research Associate

vor 2 Wochen

Kloten, Zürich, Schweiz Envista Vollzeit

Job Summary:

We are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Envista. As a Clinical Research Associate, you will play a critical role in the success of our clinical operations by ensuring the timely delivery of clinical investigations and maintaining high-quality standards.

Main Responsibilities:

  • Support the timely delivery of clinical investigations in collaboration with the Clinical Research Manager (CRM)
  • Adhere to required quality standards and laws/regulations, including ISO 14155 and ICH-GCP Guidelines
  • Independently perform monitoring visits, including site qualification, study site initiation, routine monitoring, and study site closure visits
  • Ensure source data verification (SDV) and timely query resolution
  • Assist in investigation start-up activities, such as site selection visits and review of regulatory documents
  • Establish and maintain regular contact with investigators and the ethics committee as needed
  • Prepare and maintain the investigator file, center file, and study master file
  • Communicate project-specific information to/from trial sites, document communication with investigation sites/teams, and escalate issues to CRM in a timely manner
  • Present at and participate in investigator meetings, other study trainings, and meetings as assigned
  • Support statistical evaluation of study results within the clinical operations
  • Support timely delivery of clinical documentation needed in product development projects, such as clinical investigation reports
  • Screen and identify business and product-relevant scientific literature as assigned

Requirements:

  • A Medical-related scientific degree (e.g. Bachelor, Master, Nursing qualifications)
  • Strong knowledge of ISO 14155 and ICH-GCP Guidelines
  • Minimum 1-2 years of experience in various clinical trial activities within a medical device industry, preferably in the dentistry sector
  • Knowledge of the dentistry sector and a strong scientific understanding are preferred
  • Good interpersonal skills
  • Ability to work both independently and collaboratively within a team
  • Fluency in English (reading and writing), any additional language is an advantage
  • Strong interest in data analysis, graphing, and plotting results, and report writing
  • Willingness and ability to travel, as required (25%)

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