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Clinical Research Associate

2 meses atrás

São Paulo, São Paulo, Brasil Abbvie Tempo inteiro

**Job Summary**

At AbbVie, we are seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a critical role in ensuring the successful execution of clinical studies.

**Key Responsibilities:**

  • Monitor clinical investigative sites to ensure compliance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs).
  • Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-4 studies.
  • Oversee the overall activities of site personnel and motivate them to meet study objectives.
  • Ensure quality of data submitted from study sites and assure timely submission of data.
  • Train study site personnel on the protocol and applicable regulatory requirements.
  • Manage investigator payments and negotiate investigator/hospital agreements.
  • Identify, evaluate, and recommend new/potential investigators/sites.

**Requirements:**

  • Appropriate tertiary qualification, health-related (e.g., Medical, Scientific, Nursing) preferred.
  • Minimum of 1 year of clinically-related experience, with a period of 6 months preferable in clinical research monitoring.
  • Current indepth knowledge and understanding of appropriate therapeutic indications.
  • Current indepth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable regulations.
  • Strong planning and organizational skills, with the ability to work effectively and efficiently in a dynamic environment.
  • Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.

**Additional Information:**