Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements.
Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP.
Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to.
Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines.
Guarantees that the study Investigational Product inventory and accountability is accurate and stored securely.
Ensures audit readiness at site level.
Acts in the project role of a Lead CRA as assigned.

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
Thorough knowledge of monitoring procedures.
Basic understanding of the clinical trial process.
Fluent in local office language and in English, both written and verbal.
Typically 2 years of onsite clinical monitoring experience.

Clinical Research Associate II

Key skills