Clinical Research Associate II

hace 4 semanas


Buenos Aires, Argentina BUE Fortrea Argentina S.A. A tiempo completo
Job Title: Clinical Research Associate II

At BUE Fortrea Argentina S.A., we are seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a key member of our clinical research 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, process production of reports, narratives and follow up of SAEs.
  • 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.
  • Ability to work with minimal supervision.
  • Good communication and interpersonal skills.
  • Good analytical and negotiation skills.
  • Computer competency.
  • 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, however an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
Education/Qualifications/Certifications and Licenses:
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
  • Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements.
  • Thorough knowledge of monitoring procedures.
  • Basic understanding of the clinical trial process.

We are committed to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. 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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