Key Objectives/Deliverables:

• Track the progress of a clinical trial including patient recruitment as required, trial supplies and trial documentation
• Provide administrative support for clinical research personnel, including Head of Clinical Development, Head of Trial Management, and Clinical Trials Manager
• Track and process invoices and authorized clinical trial payments to selected vendors and investigational sites, accurately and in a timely manner
• Organize and schedule appointments/meetings, internally and externally, as necessary and prepare minutes of these meetings
• Coordinate clinical trial supplies and documents to investigational sites, as directed
• Regularly update project tracking tools and systems when requested or needed
• Coordinate the medical product manufacture process if needed
• Coordinate the vendors selection process when the task is designated

Study Start-up

• Assist in the preparation of study documentation, forms and the development of administrative systems and processes
• Assist in the distribution of study documents
• Assist in the planning and preparation of Investigator meetings

Study Execution

• Assist with Ethics Committee submissions as required
• Maintain up to date participating site information (including all contact details, contracts and reports)
• Assist with the trial master file review
• Proactively identify study administrative issues

• Accountable for the management of study materials and supplies - distribution, ordering, tracking, storage, reconciliation and destruction
• Provide administrative technical support to study team
• Assist with the preparation of study-related presentation materials
• Assist with the preparation and maintenance of study files
• Assist project team with other study related activities such as organizing study meetings and scheduling travel, producing agendas and minutes for study-related meetings, assembling training and study materials, updating contact details, maintaining study documentation, assisting in the preparation of administrative documents and other tasks as required
• Participate in special projects/Trials to continuously improve processes, tools, systems and organisation

• Participate in goal setting, performance management, review of position and planning and implementation of professional development activities.
• The CTC may also undertake certain Clinical Research Associate (CRA) tasks or conduct the co-monitoring visit with CRAs from Clinical Research Organization (CRO). This will be asced as a part for the personal development. At all times, oversight of these tasks will be performed by a more senior colleague

• Complete and document mandatory training for this role within specified timelines
• Attend and document mandatory training workshops required for this role
• Comply with all applicable regulations, guidelines, SOPs and project-specific requirements
• Ensure own quality control of all relevant processes and activities performed
• Report and escalate identified issues in areas of responsibility

上班地址：王府井大街138号新东安市场T2写字楼7层