Descripción de la oferta
Responsibilities (a) Site management • Study site selection, initiation (SIV) and clinical monitoring. • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience. • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations. • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP. • Track study recruitment to ensure recruitment target is achieved in all studies. • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating. • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study. • Assemble site specific EC submission dossier, and ensure submission to EC. Training • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements. • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files. • Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety • Ensure safety information is disseminated to all sites according SOP and applicable regulations. • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration • Finalize budget and obtain signed contract from site, prior to site initiation visit. • Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system • Update and maintain Study tools/systems in a timely manner. 3. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.
