职责要求：
Drive study performance at the sites. Perform
site monitoring and other onsite visit activities according to monitoring
plan and in compliance with procedural documents . Provide the
required monitoring visit reports within required timelines. Proactively
identify study-related issues and escalates to Local Study Team as
appropriate.
Contribute to the selection of potential sites
and investigators. Train, support and advise Investigators and site staff
in study related matters.
Obtain and maintain essential documentation in
compliance with ICH-GCP, Procedural
Documents and local regulations. Manage study supplies (ISF, CRF, etc),
drug supplies and drug accountability at study sites.
Perform source data verification according to SDV
plan. Ensure data query resolution. Work with data management to ensure
quality of the study data.
Ensure accurate and timely reporting of Serious
Adverse Events.
Share relevant information on patient recruitment
and study site progress within local Study Team. Update VCV and other
systems with data from centres as per required timelines
Prepare for activities associated with audits and regulatory
inspections in liaison with local Study Team Lead and QA.
Additional tasks assigned by manager, include but
not limited: study level tasks associated with Country Study Manager
(CSM), act as a mentor for junior team member, co-monitor less experience
CRA within study team.
Contribute to process improvements, knowledge
transfer and best practice sharing.
任职资格：
· Bachelor degree in biological science or healthcare-related
field, or equivalent
· Minimum 3-year experience as CRA or other related fields.
· Have proven track record on performance of site management
and monitoring delivery.
· Solid understanding of the clinical dataflow
· Excellent knowledge of the clinical study and drug development processes, GCP/ICH guidelines and relevant local regulations
· Good computer skills in Microsoft and other
software.
· Fluent in both oral and written English.
· Good knowledge of the Monitoring Process, such as understanding of the
Study Drug Handling Process and the Data Management Process, etc.
· Demonstrates ability to prepare and deliver study related training
materials
· Ability to look for and champion more efficient and effective methods/processes
of delivering quality clinical trials with reduced budget and in less time.
· Very good written and verbal communication skills, negotiation,
collaboration and interpersonal skills.