Clinical Research Associate II
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Job Description
Clinical Research Associate II monitoring investigator sites and clinical trial data for Parexel’s global healthcare solutions. Ensuring ICH/GCP compliance, patient safety, documentation, and study quality.
Responsibilities:
- Conduct source data verification and ensure clinical trial data are submitted to data management in a timely manner
- Identify study-conduct issues and ensure appropriate closure
- Manage investigator site workload and ensure studies meet key objectives
- Ensure studies comply with ICH/GCP, local laws, and client SOPs
- Maintain patient safety and report safety issues according to regulatory requirements
- Inform Principal Investigators and site staff of issues
- Develop corrective and preventive actions with investigators and site personnel
- Manage all aspects of site management from site selection through study closeout
- Train site staff on protocols, amendments, and client processes
- Maintain sufficient knowledge of the product, protocol, and therapy area
- Monitor data quality and ensure timely system entry
- Report study progress after each site visit and manage issues to closure
- Maintain site-level clinical trial registry information
- Obtain and maintain Investigator Initiation Package documentation, Site Master File, monitoring logs, ELARA, and/or Trial Master File records
- Quality-control relevant documents and generate site monitoring reports
- Complete required training, timesheets, expense reports, CV updates, and compliance activities
Requirements:
- Computer Literacy (word processing and spreadsheets, PowerPoint)
- Proficient in Chinese
- Good command of written and spoken English is required
- Good interpersonal skills and communication ability
- Flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks, prioritize workload, and maintain attention to detail
- Willingness to work in a matrix environment and value teamwork
- At least 1.5 years of Clinical Monitoring/Site Management experience (2 years preferable)
- Good knowledge of ICH/GCP and relevant international and local clinical research regulations
- Degree in Life Science, Nursing, Pharmacy, or another relevant educational background
- Bachelor’s degree or above, or equivalent
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