Clinical Research Associate II

hace 2 meses

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

Fortrea is seeking a highly motivated and experienced Clinical Research Associate II to join our team. As a key member of our clinical development 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 ensure audit readiness at the site level.
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).

Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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