Clinical Research Assistant

hace 1 mes

Ciudad de México, Ciudad de México Covance Latinoamérica A tiempo completo

Covance Latinoamérica: A Leader in Clinical Research

We are seeking a highly skilled Clinical Research Assistant to join our team in Mexico. As a Clinical Research Assistant, you will play a critical role in the success of our clinical trials.

Key Responsibilities:

  • Act as contact for project team and study sites.
  • Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
  • Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data.
  • Assist with the management of study supplies and organize shipments.
  • Create, update, track, and maintain study-specific trial management files, tools, and systems.
  • Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators' meetings).
  • Co-ordinate meetings with clients, investigators, and project team, including taking minutes.
  • Ensure compliance with Covance S.O.P.s, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work.
  • Provide input in writing Monitoring Conventions as assigned.
  • Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.

Requirements:

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
  • In lieu of the above requirement, candidates with one (1) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
  • Basic understanding of biology and biological processes.
  • Good organizational and time management skills.
  • Good communication skills, oral and written.
  • Exhibit general computer literacy.
  • Works efficiently and effectively in a matrix environment.
  • Fluent in local office language and in English, both written and verbal.

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