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. Qualifications3.1 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.
