Clinical Research Associate

Há 16 horas


São Paulo, São Paulo, Brasil AbbVie Tempo inteiro
About the Role

We are seeking a highly skilled Clinical Research Associate to join our team at AbbVie. As a Clinical Research Associate, you will play a critical role in ensuring the successful execution of clinical studies, from start-up to close-out.

Key Responsibilities
  • Monitor clinical investigative sites to ensure adherence to federal regulations, Good Clinical Practices (GCPs), and AbbVie Standard Operating Procedures (SOPs);
  • Conduct site qualification, initiation, interim monitoring, and study close-out visits for Phase 1-4 studies;
  • Oversee site personnel and ensure action plans are put into place to ensure compliance and regulatory inspection readiness;
  • Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events;
  • 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 in clinical research monitoring;
  • Current in-depth knowledge and understanding of appropriate therapeutic indications and regulations governing clinical research;
  • Strong planning and organizational skills, analytical and conceptual capabilities, and ability to communicate with clarity;
  • Demonstrated business ethics and integrity.
About AbbVie

AbbVie is committed to acting with honesty, promoting innovation, changing lives, serving our community, and promoting diversity and inclusion. We employ the most qualified professionals without discrimination based on race, color, religion, nationality, age, sex (including pregnancy), physical or mental disabilities, diseases, genetic information, identity or expression of gender, sexual orientation, marital status, or any other protected status under law.



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