Clinical Research Associate II
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Job Description
Clinical Research Associate II monitoring investigator sites and ensuring clinical-trial data quality for Parexel’s clinical development solutions. Managing site documentation, compliance, reporting, and patient safety.
Responsibilities:
- Conduct source data verification (SDV) and ensure clinical trials data are submitted to data management in a timely fashion
- Identify issues that may impact the conduct of the study and ensure appropriate closure
- Proactively manage a greater investigator site workload commensurate with experience
- Ensure studies comply with ICH/GCP, local laws, and Client SOPs and procedures
- Maintain patient safety and report safety issues according to regulatory requirements
- Inform the Principal Investigator and site staff of issues
- Develop corrective and preventative actions with PI 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 product, protocol, and therapy-area knowledge for investigator discussions
- Interact with healthcare professionals
- Ensure monitored data meets target quality standards and is entered into Client systems timely
- Report study progress after each investigational-site visit
- Identify, catalogue, and manage issues to closure
- Maintain accurate site-level information on the corporate clinical trials registry
- Obtain information for Investigator Initiation Package documentation and assist CTA with site setup
- Maintain the Site Master File and log
- Ensure ELARA and/or Client TMF is complete and accurate
- Quality-control relevant documents in ELARA and/or TMF
- Generate site monitoring reports and maintain monitoring logs
- Complete required training, timesheets, expense reports, and CV updates
- Maintain knowledge of and 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, good at communication
- A flexible attitude with respect to work assignments and new learning, quickly-learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Willingness to work in a matrix environment and to value the importance of teamwork
- At least 1.5 years (2 years preferable) of Clinical Monitoring/ Site Management experience
- Good knowledge of ICH/GCP, 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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