1. Job Purpose
1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.
1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.
2.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. The excellent candidates will not be restricted to the current requirements;
3.2 At least 1 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.
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