南京招聘

职位描述：
*Job Description
? Assume the ability to meet the requirements of a CTS I with a high degree of proficiency and
autonomy
? Take responsibility for specific tasks on projects, or acts as the main CTS contact on individual
projects
? Train team members on selected tasks
? Mentor and train new staff as appropriate
? Action site selection strategy
? Refine project-specific site selection strategy at a country level
? Identify new potential Investigators and enter/update clean information into the tracking
systems
? Ensure feasibility, review and approval of site identification list coming from FCI
? Conduct country specific feasibility and/or site pre-qualification and/or or remote qualification
visits and/or site selection activities (except for on-site qualification visits, which will be done
by CRAs)
? Create country specific / site specific (if necessary) Informed Consent Form (ICF)
? Review and approve country specific ICFs (if necessary)
? Prepare and negotiate clinical site agreement at a site leve
? Prepare and submit Institutional Review Board (IRB)/Ethics Committee (EC) applications until
final approval received (initial submission / Amendments)
? Customize SRP Guidelines
? Collect and compile regulatory documents in collaborations with the CRA
? On a regular basis conduct outbound and receive inbound calls to:
? Review recruitment plan
? address/resolve issues pending from qualification visit
? address protocol questions
? check on site staff assignment
? request outstanding documents
? Follow-up on appropriate site related questions
? Review and approve SRP
? Immediately update tracking system once regulatory documents are approved
? Adapt drug label for country requirements in cooperation with Regulatory and the Logistics
Team (if applicable)
? Organize translations per country/regulatory/client requirements
? Submit safety updates to IRB/IEC (if applicable)
? Prepare and submit MOH/RA documentation and follow-up until final approval received
(Initial submission/Amendments), where applicable in countries fulfilling responsibilities of
regulatory services
? Assist with QC/audit of central files and liaise with Research Regulatory Compliance (RRC)
personnel as required
*Job Qualifications
Substantial Clinical experience in Clinical Research required 举报 分享

精鼎医药（Parexel International）是全球领先的药物研究合同委托机构（CRO），总部位于美国生物医药圣地马萨诸塞州的波士顿附近，在世界各地拥有71个办事处，约17,600 名员工，为超过100个国家的客户提供服务。

精鼎医药成立于1982年，在三十多年的历程中，一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商，并且取得了卓越成果。目前，我们能够提供全世界CRO领域全面的新药临床阶段研发服务，服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。

将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案，可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。