Clinical Research Associate(CRA)_Taipei, Taiwan 需出差~北中南 JD: -Build relationships with investigators and site staff -Participate in Investigator and other external or internal meetings as required -Arrange on-site visits and logistics -Perform on site visits in accordance with the monitoring plan -Conduct on-site study-specific training (if applicable) -Perform site facilities inspection -Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations Monitor and maintain ICH-GCP compliance -Responsible for the completeness and quality of the on-site files -Respond to site issue alerted from Clinical Monitoring Associate (i.e., non-responsive site, Protocol -Deviations concerns, quality issues etc., items that require face to face interaction) -Collect SRP documents during QV and other visits as needed -Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit -Update all relevant tracking system on an ongoing basis -Collaborate with CMA on site issues/actions -Generate visit/contact report in accordance with monitoring plan -Code and scan Central File documents where applicable Ship relevant wet-ink signature documents to the Assistant or back to the site Escalate any issues that require immediate action to the Coordinator/GRO Lead Inform responsible Coordinator of work status regularly Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor Attend audits / Regulatory Inspection if requested Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL WSOP and stud specific procedure Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims) Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor Required: Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word Strong regulatory knowledge including GCP Excellent interpersonal, verbal and written communication skills Sound problem solving skills Ability to successfully work in a (`virtual? team environment Sound presentation skills Consultative skills Client focused approach to work with the ability to interact professionally within a client organization Ability to prioritize multiple tasks and achieve project timelines Able to take initiative and work independently Sense of urgency in completing assigned tasks Able to travel a minimum of 65% on average Effective time management in order to meet daily metrics or team objectives Shows commitment to and performs consistently high quality work NTD:一年经验40k~50k两年以上60~70K(视经验调整) -- 找工作的最佳夥伴 --> job hunter: Kelly Chen 联络电话: 8780 6822 伊媚儿: [email protected] 地址: 台北市信义区松仁路97号群益金融大楼11楼 (市政府捷运站3号出口) --

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