Description
We are seeking a Clinical Research Associate to join our team in Chengdu. As a Clinical Research Associate, you will be responsible for site management and monitoring of clinical trials.
Responsibilities:
- Manage clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements
- Conduct site monitoring visits, 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
- Safeguard data integrity by reviewing source documents, generating queries, and resolving issues
- Confirm site regulatory documents and eTMF/Sponsor documents are complete and current
- Ensure adherence to global quality control and CRA performance metrics
- Travel to study sites, which may include air travel, and prepare trip reports
- Independently perform eCRF review, source data verification, and query generation and resolution
- Assist with administration of clinical research projects, recruiting investigators, and site management
- Update and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems
Qualifications:
- University or college degree, or certification in a related allied health profession
- Thorough understanding of ICH GCP Guidelines and 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
Experience:
- Minimum of 2 years of Clinical Monitoring experience
- Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines
- Ability to work with minimal supervision
Preferred Qualifications:
- Thorough working knowledge of Fortrea SOPs for site monitoring
- Additional years of experience in a related field
- Phase I monitoring experience
- Life Science or Nursing qualification
- Specific skills, systems, certifications, and/or licenses
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
- 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 (travelling to study sites)