職位描述
Major responsibilities
? Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents.
? Assist in coordination of clinical studies from site selection through site activation. That involves but not limited to
？ Conduct SQV in selected sites;
？ Take EC application and get EC approval from confirmed sites;
？ Negotiate, finalize and get final signing of the clinical study agreement and related amendments from confirmed sites;
？ Assist to get HGR application required documents from confirmed sites.
？ Assist local study team to prepare site initiation visit in site.
? Actively participate in local Study Delivery Team meetings and work cross functionally with Clinical Trial Support Team in China SM&M.
? Activate study sites in compliance with Procedural Documents.
? Share information (metrics) on study site progress towards activation within local Study Delivery Team and China SM&M leadership as required.
? Drive delivery of regulatory documents at the sites. Proactively identify delays in start-up activities and the risks to the activation plan.
? Update IMPACT and other systems with data from centres as per required per Site Optimization Team (SOT) process.
? Ensure regulatory binders are provided for study site start up and/or delivered as per SOT process and agreement with Local Study Delivery Team.
? Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
? Ensure compliance with company’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
? Ensure completeness of the Study Master File for study start-up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva).
? Ensure that all start up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
? Contribute to the production of study start up documents, ensuring template and version compliance.
? Create and/or import clinical-regulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the Authoring Guide for Regulatory Documents to support publishing in ANGEL.
? Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems.
? Regular communication with key/mega site and influence the trial delivery in hospital level.
Additional Responsibilities May Include
? Contribute to process improvements, knowledge transfer and best practice sharing.
? Actively share applicable information that may be relevant to other functions.
Requirement:
? University degree in related discipline, preferably in life science, or equivalent qualification.
? Fluent knowledge of spoken and written English.
? In total 2-4 years working experience. Previous experience as CRA is a must, previous experience as SSU is a plus.
? Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
? Good knowledge of relevant local regulations.
? Basic understanding of the drug development process.
? Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
? Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
? Ability to travel nationally as required.
