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Clinical Research Associate II

hace 2 meses

Madrid, Madrid, España Allergan A tiempo completo
Job Description

Job Title: Clinical Research Associate II

Company: Allergan

Job Summary:

We are seeking a highly skilled Clinical Research Associate II to join our team. The successful candidate will be responsible for monitoring clinical investigative sites and ensuring the successful execution of clinical studies.

Responsibilities:

  • Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-3 studies.
  • Ensure adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs).
  • Proactively manage site activities and ensure compliance with regulatory requirements.
  • 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.

Qualifications:

  • Appropriate tertiary qualification, health-related (e.g., Medical, Scientific, Nursing) preferred.
  • Minimum of 2 years of clinically-related experience in Oncology.
  • Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
  • Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable regulations.

About Us:

Allergan is a global pharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that solve serious health issues. We strive to have a remarkable impact on people's lives across several key therapeutic areas.