Key Responsibilities:
1. Project Management and Study Site Management
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This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical studies in accordance with SOPs, ICH-GCP, GCP and other applicable regulations.
The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.
Responsibilities include:
* Site management including study site selection, initiation (SIV) and clinical monitoring;
* Performing pre-study visits to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience;
* Preparing and conducting SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations;
* Ensuring Principal Investigator/study staff complies with safety reporting requirements as defined in protocol, SOP, ICH-GCP and GCP;
* Tracking study recruitment to ensure recruitment target is achieved in all studies;
* Conducting monitoring visits according to SDV plan and SOP; addressing issues with sites and completing monitoring visit reports in a timely manner coordinating;
* Ensuring timely coordination of study materials to the site for start-up and throughout the study;
* Assembling site-specific EC submission dossiers and ensuring submission to EC;
* Providing ongoing training to site staff regarding ICH-GCP, GCP, study protocol and requirements;
* Conducting site initiations to ensure that the site has a thorough understanding of the study protocol and requirements;
* Ensuring timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down; maintaining and updating these documents in investigator files, trial master files;
* Preparing/completing study records' archiving according to protocol and sponsor requirements;
* Ensuring safety information is disseminated to all sites according SOP and applicable regulations;
* Ensuring SAEs are reported within the timeline in compliance with SOPs and applicable regulations;
* Finalizing budgets and obtaining signed contracts from sites prior to site initiation visits;
* Ensuring study payment schedules are executed and retaining relevant documents/receipts;
* Updating and maintaining study tools/systems in a timely manner.
Qualifications:
* Bachelor degree or above in Medical, Pharmacology or Biology-related majors;
* At least 1 year of CRA experience;
* Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;
* Good skills on Microsoft Word, Excel, PPT and Outlook.