Clinical Research Associate

We are seeking a Clinical Research Associate to join our team in Beijing. As a Clinical Research Associate, you will be responsible for site management and monitoring of clinical trials.

Job Summary: The successful candidate will have site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and applicable project plans and Sponsor requirements.

Key Responsibilities:

• Conduct site monitoring responsibilities for clinical trials, including pre-study, site initiation, process monitoring, routine monitoring, and close-out visits
• Prepare and implement project plans related to Clinical Monitoring responsibilities
• Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements
• Safeguard data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines
• Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial
• Guarantee that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
• Ensure adherence to global quality control and CRA performance metrics
• Ensure audit readiness at site level
• Act as a Lead CRA as assigned

Requirements:

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution
• 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
• A minimum of 2 years of Clinical Monitoring experience

Preferred Qualifications:

• Thorough working knowledge of Fortrea SOPs for site monitoring
• One or more additional years of experience in a related field
• Phase I monitoring experience
• Life Science or Nursing qualification
• Specific skills, systems, certifications, and/or licenses preferred

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
• Standard office and/or home working environment
• Clinical Research Unit and hospital environment (administrative only)
• Risk of eye strain
• Will involve outside of normal office hours as required by the role
• Travel Requirement is 60% of the time (traveling to study sites)