CRAII 广州

月薪： 0.8-1万/月

该公司所有职位
  • 1年经验
  • 本科
  • 招若干人
  • 11-09 发布
  • 五险一金
  • 员工旅游
  • 专业培训
  • 弹性工作

职位描述

职位描述： Key Accountabilities?Build relationships with investigators and site staff?Participate in Investigator and other external or internal meetings as required?Arrange on-site visits and logistics (e.g. travel arrangements)?Perform on site visits and generate visit/contact reports 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?Responsible for the completeness and quality of the on-site files?Respond to site issues alerted by the project team (i.e, non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)?Collect SRP documents during site 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?Code and scan Central File documents where applicable?Ship relevant wet-ink signature documents to the Assistant or back to the site?Monitor and maintain compliance with ICH-GCP Guidelines, local regulatory requirements, PAREXEL and/or Client SOPs, and study specific procedures?Escalate any issues that require immediate action to the CRA Coordinator or COL?Attend audits / Regulatory Inspection if requested?Inform responsible CRA Coordinator/COL/Manager of work status regularly?Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)?Recognize out of scope activities, escalate and communicate to the COL?Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects?Perform co-monitoring visits with less experienced CRAs or at problem sites as required?Function as mentor and role model for less experienced CRAs and/or team members to ensure study specific training?If applicable, act as an independent CRA Coordinator or COL coordinating a small to moderate team or multiple small size protocols?If acting as CRA Coordinator or COL, represent function in external client meetings and presentations such as investigator meetings and bid defenses as required. May represent PAREXEL at professional meetings / conferences?If acting as CRA Coordinator or COL, participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.Skills?Strong regulatory knowledge including GCP?Client-focused approach to work, with the ability to interact professionally within a client organization?Ability to successfully work in a (‘virtual’) team environment?Excellent interpersonal, verbal and written communication skills?Effective time management in order to meet daily metrics or team objectives?A flexible attitude with respect to work assignments and new learning?Able to take initiative and work independently?Sense of urgency in completing assigned tasks?Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail to achieve project milestones?Show commitment to and perform consistently high quality work?Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word.?Sound presentation skills?Consultative skills?Ability to solve problems through win-win solutions by using a logical, systematic, sequential approach.?Able to travel a minimum of 65% on average?Holds a driving license where required?If acting as CRA Coordinator or COL:oGive others appropriate latitude to make decisionsoCarefully weigh the priority of project tasks and directs team accordinglyoAbility to make appropriate decisions in ambiguous situationsoAbility to lead a “virtual”, global team as requiredoUnderstand the strengths and development areas of team membersoEnlist the support of team members in meetings goalsEducation?Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experienceLanguage Skills?Competent in written and oral EnglishMinimum Work Experience?Adequate monitoring experience or equal experience in clinical research 职能类别： 临床研究员

联系方式

中国广州市越秀区中山三路33号中华国际中心（中华广场）写字楼A座1406/07

公司信息

精鼎医药研究开发(上海)有限公司(PAREXEL International)，成立于1982年，是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国，分支机构遍布欧、美、亚、大洋四大洲，且于亚洲13个国家和地区设立了分支机构，致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成，服务团队集合各种不同专业领域的人才。我们重视与客户的承诺，更重视人才的培育和养成，我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境，期许同仁与公司一同成长，迈向未来。 愿景（Vision）： 创造一个在亚太地区具有国际竞争力的最精良CRO团队。 发展使命（Mission）： 1．争取国际大药厂委托，执行符合国际水准的跨国性临床试验。 2．协助亚太生技及制药产业建立新药开发模式，以提升产品研发能力，幷促使产品国际化。 3．以提升临床试验品质为宗旨，拓展全球市场为目标，整合计算机及通讯科技，在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。 4．建立一个以亚洲人种高发生率疾病的基因数据库，以提供国际性新药研发机构所须之基因信息，协助其缩短药物开发时程，幷提高研发成功率。 公司福利和人才培养计划： 保险类： 1. 社会保险(依照国家规定)及住房公积金； 2. 团体保险（包括寿险、意外暨医疗保险）； 3. 补充医疗保险； 制度类： 1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣，设计符合其个人之生涯规划； 2. 完整的教育训练：每年公司均针对所有员工，提供完整之教育训练； 3. 顺畅的升迁管道及可转调其它部门；如有职缺，亦可申请调至海外各子公司； 请 / 休假制度： 1. 服务第一年即享有14天年假, 后续年休假天数则依据服务年资及公司制度而定； 2. 一年可享12天不扣薪病假； 3. 员工旅游, 年度体检； 精鼎医药将以培养国际性的人才为目标，欢迎具有国际观之人才加入。 应聘方法： 1.    在线投递； 2.    请登录我们的公司网站直接投您的简历（https://jobs.parexel.com/search-jobs） 我们在收到您的简历之后，会尽快与您联系。 谢谢！

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