Clinical Research Associate II

hace 1 semana


Buenos Aires, Argentina BUE Fortrea Argentina S.A. A tiempo completo
Job Summary

We are seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team at BUE Fortrea Argentina S.A. As a key member of our clinical operations team, you will be responsible for site monitoring and site management, ensuring the successful execution of clinical studies according to Company, and/or Sponsor Standard Operating Procedures, and local regulatory guidelines.

Key Responsibilities
  • Conduct site monitoring and site management activities, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaison with vendors.
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
  • Verify that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Monitor data for missing or implausible data and ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools.
  • Prepare accurate and timely trip reports and track and follow up on Serious Adverse Event (SAE) reporting.
  • Perform other duties as assigned by management.
Requirements
  • A minimum of 1 (One) year of Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
  • Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines.
  • Good planning, organization, and problem-solving abilities, as well as good communication and interpersonal skills.
  • Fluent in local office language and in English, both written and verbal.
Preferred Qualifications
  • One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).

We offer a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. If you are a motivated problem-solver and creative thinker who shares our passion for overcoming barriers in clinical trials, we encourage you to apply for this exciting opportunity.



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