Clinical Research Associate II
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Job Description
Clinical Research Associate II monitoring investigator sites and clinical trial data for Parexel, a global clinical development services provider. Ensuring compliance, documentation, and patient safety.
Responsibilities:
- Conduct source data verification and ensure clinical trial data are submitted to data management promptly
- Identify study-conduct issues and ensure appropriate issue closure
- Manage investigator site workload and ensure studies run efficiently and meet objectives
- Ensure compliance with ICH/GCP, local laws, and client SOPs and procedures
- 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 sites 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 for investigator discussions
- Interact with healthcare professionals to enhance client credibility
- Ensure monitored data meets quality standards and is entered into client systems promptly
- Report study progress after site visits and catalog and manage issues to closure
- Maintain accurate site-level information in the clinical trials registry
- Obtain and maintain Investigator Initiation Package, Site Master File, ELARA, and/or Trial Master File documentation
- Quality-control relevant documents and generate monitoring reports
- Maintain monitoring logs
- Complete required training, timesheets, expense reports, and CV updates
- Comply with Parexel processes, ICH-GCP, and applicable requirements
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; quick learner
- 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 (2 years preferable) of Clinical Monitoring/Site Management experience
- Good knowledge of ICH/GCP and relevant international and local regulations relating to Clinical Research
- Degree in Life Science, Nursing, Pharmacy, or other relevant education background
- Bachelor’s degree or above, or equivalent
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