Description
We are seeking a Clinical Research Associate to join our team in Nanjing or Hangzhou. As a Clinical Research Associate, you will be responsible for site management and monitoring of clinical trials.
Job Summary: You 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. You will conduct site monitoring responsibilities for clinical trials, prepare and implement project plans related to Clinical Monitoring responsibilities, and ensure the protection of subjects.
Key Responsibilities:
- Conduct site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines, and GCP
- 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
- 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
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
Preferred Qualifications:
- Thorough working knowledge of Fortrea SOPs for site monitoring
- One (1) or more additional years of experience in a related field
- Phase I monitoring experience
- Life Science or Nursing qualification
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)