长沙招聘

职位描述：
职责描述：
与研究中心合作，进行伦理文件准备与递交以及合同谈判，并与内部相关部门合作确保研究中心顺利启动 。
解决研究中心启动过程中发生的问题。
管理维护SSU相关数据并保证其准确性。
任职要求：
英语熟练，
本科以上学历， 有SSU 或CRA相关工作经验者优先；
优秀硕士应届毕业生也可考虑
Job Responsibilities:
?Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.
?Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
?Review and provide feedback to management on site performance metrics.
?Serve as contact for investigative sites, designated project reports, communications, and customer service.
?Resolve site issues and determine status for product shipment.
?Work with regulatory team members or sponsor to secure authorization of regulatory documents.
?Work with legal team members or sponsor to secure authorization of contracts.
?Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
?Inform team members of completion of regulatory and contractual documents for individual sites.
?Work with team members in preparation of regulatory submissions per work instructions.
?May serve as a SSU Team Lead for country or region as needed. Coordinate activities for projects within area of specialization.
?May translate or review completed translations of critical documents.
?May participate in feasibility and/or site identification activities.
Requirements:
?Bachelor's Degree in a related field and 1 year clinical research experience; or equivalent combination of education, training and experience
?In-depth knowledge of clinical systems, procedures, and corporate standards
?Strong knowledge of medical terminology and regulations
?Broad knowledge of clinical research
?Strong knowledge of Microsoft Office and e-mail applications
?Effective communication, organizational, and interpersonal skills
?Ability to work independently and to effectively prioritize tasks
?Ability to manage multiple projects
?Attention to detail
?Ability to establish and maintain effective working relationships with coworkers, managers and clients 举报 分享

QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
 
If that is your passion, we have a place for you.