南京招聘

*Job Description
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 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

*Job Qualifications
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
Holds a driving license where required
Effective time management in order to meet daily metrics or team objectives
Shows commitment to and performs consistently high quality work

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。