Clinical Research Associate II

2 giorni fa

Milano, Lombardia, Italia Pharmiweb A tempo pieno
Job Title:
Clinical Research Associate II

As a leading global contract research organization, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in over 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.


We are seeking a highly motivated and experienced Clinical Research Associate (CRA) to provide on-site monitoring support for clinical trials. The successful candidate will have a thorough understanding of ICH GCP Guidelines and local regulatory requirements.


Responsibilities:


  • Verify study training records and conduct site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines, and GCP.
  • Safeguard data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
  • Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.

Requirements:


  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution.
  • Mandatory CRA certification as per Ministerial Decree.
  • Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.

Experience:


  • A minimum of 2 years of Clinical Monitoring experience.

Physical Demands / Work Environment:


  • Must be able to sit at a computer for long periods of time.
  • Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.

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