Clinical Research Associate II (FSP)

Key Accountabilities:

Monitoring and Management of Investigator Sites

• Conducts source data verification (SDV) and ensure clinical trials data are submitted to data management in a timely fashion
• Identifies issues that may impact on the conduct of the study and ensure appropriate closure of all issues
• Proactively manages a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met
• Ensures studies are run in line with ICH/GCP, local laws and Client Standard Operating Procedures (SOPs) and procedures
• Ensures patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements
• Informs the Principal Investigator (PI) and site staff of all issues
• Agrees and develops corrective and preventative actions with PI and site personnel to close all open issues
• Responsible for all aspects of site management from collaboration on site selection to study closeout
• Trains site staff on the protocol, protocol amendments and Client processes
• Understands the product, the protocol, and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team
• Interacts with health care professionals in a manner, which enhances Client’s credibility with the customer

Data Quality

• Ensures that data monitored meets target quality standards
• Ensures that data is entered into Client systems in a timely manner

Reporting

• Reports on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred
• Ensures all issues are correctly identified and catalogued
• Proactively manages issues to appropriate closure
• Maintains accurate site-level information on corporate clinical trials registry

Documentation

• Obtains critical information to enable generation of Investigator Initiation Package (IIP) documentation
• Assists Clinical Trial Assistant (CTA) in gathering IIP documentation where required to ensure timely site set up
• Maintains the Site Master File (SMF) and SMF log
• Ensures Electronic Library and Records Archive (ELARA) and/or Client Trial Master File (TMF) is complete and accurate
• QC relevant documents in ELARA and/or TMF in a timely manner
• Generates site monitoring reports
• Maintains all appropriate monitoring logs

Compliance with Parexel standards

• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements

Skills:

• 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

Knowledge and Experience:

• At least 1.5 years (2 years preferable) of Clinical Monitoring/ Site Management experience, global study monitoring experience is preferred
• Good knowledge of ICH/GCP, relevant international and local regulations relating to Clinical Research

Education:

• Degree in Life Science, Nursing, Pharmacy, or other relevant education background
• Bachelor’s degree or above, or equivalent