广州招聘

Job purpose

To ensure that clinical trials are conducted in accordance with Good Clinical Practice and ISO guidelines, local regulatory requirements and CRTC (Clinical Research and Trials Centre ) SOPs. To assist clinical trials teams in managing ethics and regulatory issues related to the conduction of clinical trials and maintaining the compliance systems in place.

Key responsibilities:

·Liaise with CRTC staff and monitor local, interstate and overseas clinical trials for adherence to ICH/GCP, ISO, local regulatory guidelines and CRTC SOPs, including critical document review.

·Assist in the training of new staff on clinical trial conduct: e.g. ICH/GCP, ISO, Ethics procedures, protocols, monitoring and audits.

·Assist the Clinical Operations Manager with review, revision and implementation of CRTC SOPs and processes to streamline and continually improve the CRTC.

·Monitor and maintain quality objectives.

·Identify SAEs, AEs and other participant safety related issues and ensure appropriate reporting, follow-up action and documentation per applicable guidelines and protocol requirements.

·Provide a written, accurate and complete monitoring report to project managers and follow up on action items generated as a result of monitoring, to ensure a satisfactory resolution.

·Maintain appropriate files per ICH/GCP, ISO and CRTC SOPs.

·Assist the Clinical Operations Manager with other study-related and departmental duties as required.

·Mentor junior colleagues within the clinical department.

Requirements:

·Bachelor degree or above in either medical or biological science.

·Experience in conduct and monitoring aspects of clinical trials.

·An up to date knowledge of ICH/GCP, ISO and local regulatory requirements

·Attention to detail and adherence to deadlines and ability to work under pressure.

·Proven ability to liaise effectively with customers and key staff at all levels.

    华柏恩视觉研究中心（以下简称“中心”）的总部位于澳大利亚新南威尔士大学，分支及合作机构遍及全球主要国家，致力于视光学科研和教育的国际化发展。中心的前身是1975年成立于澳洲新南威尔士大学的视光学院角膜和角膜接触镜研究中心 (CCLRU) 。三十多年来，作为全球领先的视觉科技转化研究基地，中心研制出了对于眼保健具有划时代意义的科研技术成果，其中有代表性的如目前广泛用于角膜接触镜的硅水凝胶材料，以及近视周边像差控制技术等。
   广州市华柏恩视觉科技有限公司是华柏恩视觉研究中心于2012年在中国建立的第一家分支机构，并与中山大学中山眼科中心合作建立了“中澳眼视光学联合研发中心”（Australia China Centre for Optometry Research and Development, ACCORD），在综合临床研究 --尤其是新型角膜接触镜材料和眼科仪器及技术的研发等方面——开展多方面和跨学科的合作。