**Primary Function** **职责概述** To response for regulatory clinical trial and be a key initiator of related activities to ensure the clinical trials are conducted on time and operation in compliance. **Major Responsibilities** **主要职责** + To support manager to coordinate new sites for clinical trials; Evaluate new site capability and compliance. + To manage the clinical trial site database. Collect and analyze the clinical trial procedures, IRB documents, IRB/EC frequency, contract information; Monitor on line of clinical trial. + Coordinate and manage the locked sites to ensure the clinical trial operation in unique protocol and standard. + Draft clinical trial protocol to meet the regulatory regulation and guideline. Adjust the supplementary requirement of authorization agency on clinical trial. + Coach the CT persons and actualize the CT operation when necessary. + Response the CT sample management and adjustment. + To make order for clinical trial assays and coordinate with supply chain to ensure the on-time shipment. Original document and data management and archive. + Explain to evaluation expert if necessary. Monitor on line of clinical trial. + Receive clinical trial regulation and GCP training. + Must deal with the self-inspection, prepare for the on-site inspection and its related document preparation. To ensure all steps are on-time, included but not limited the IRB approval, contracts, filing, sample collection and testing, signature and stamp etc. To ensure the feasibility and quality of clinical trial protocol. **Requirement(education, background,…etc)** **要求** + Bachelor or above + Background is with Clinical Laboratory immunology, clinical medicine or related specialty. + Minimum 3 to 5 years Clinical trial experience, technical support or registration experience of IVD is preferred. + Skills on English listen, speak, writing. + Experienced on statistical software is preferred. + Expertise in communication, managing multiple priorities and computer literacy. + Knowledge and experience in international standards (ICH/GCP), and local regulations; + Global study experience is preferred. + Prefer to MNC working or internship experiences. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com