When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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 complies with Parexel processes, ICH- GCPs 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
