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 monitoring and site management for clinical studies according to Company and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.
Responsibilities:
- Conduct routine monitoring and closeout of clinical sites
- Maintain study files and conduct pre-study and initiation visits
- Liaise with vendors and perform other duties as assigned
- Ensure the protection of study patients by verifying informed consent procedures and protocol requirements
- Monitor data for missing or implausible data
- Ensure audit readiness at the site level
- Travel may be required, including air travel
- Prepare accurate and timely trip reports
- Interact with internal work groups to evaluate needs, resources, and timelines
- Act as contact for clinical trial supplies and other suppliers
- Perform registry management and feasibility work as prescribed in project plans
- Participate in Quality Control Visits and follow-up on Serious Adverse Event reporting
- Independently perform CRF review and query generation and resolution
- Assist with training, mentoring, and development of new employees
- Coordinate designated clinical projects as a Local Project Coordinator
Qualifications:
- University or college degree in a related allied health profession
- Basic knowledge of Regulatory Guidelines and clinical trial process
- Fluent in local office language and in English, both written and verbal
- 1 year experience in a clinical monitoring related role
- Valid Driver's License
Preferred Qualifications:
- Additional experience in a related field
- On-site monitoring experience
- Ability to maintain confidentiality of data and information
- Demonstrated ability to conduct clinical operations activities effectively and efficiently
- Understanding of medical and clinical research terminology and clinical research processes