武汉招聘

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, Con Med) 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:
o Give others appropriate latitude to make decisions
o Carefully weigh the priority of project tasks and directs team accordingly
o Ability to make appropriate decisions in ambiguous situations
o Ability to lead a “virtual”, global team as required
o Understand the strengths and development areas of team members
o Enlist the support of team members in meetings goals

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。