Cra I (Xico)

Cra I (Xico)

17 oct
|
Fortrea
|
Xico

17 oct

Fortrea

Xico

Clinical Research Associate responsible for site management and monitoring of clinical trials at Fortrea. Conducts pre-study through close-out visits, ensures regulatory compliance, maintains data integrity, and manages investigational product accountability in accordance with ICH GCP guidelines and company procedures.
Responsibilities
Conduct site initiation, routine monitoring, and close-out visits per SOPs and ICH GCP
Verify informed consent procedures and protocol adherence to protect study subjects
Perform source document review and verification, generate and resolve data queries
Ensure investigational product inventory accuracy and secure storage per protocol
Prepare monitoring plans, trip reports, and site initiation materials as assigned




Requirements
University degree or allied health certification (e.g., nursing licensure) or equivalent experience
Minimum 2 years clinical monitoring experience
Fluent in local office language and English, written and verbal
Thorough understanding of ICH GCP guidelines and local regulatory requirements
Ability to monitor sites independently with minimal supervision
Knowledge of serious adverse event reporting and follow-up procedures
Strong planning, organization, and problem-solving abilities

📌 Cra I (Xico)
🏢 Fortrea
📍 Xico

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