北京招聘

职位描述：
The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect
of designated projects in accordance with applicable SOP and regulations. Responsibilities include
performing clinical on-site monitoring activities (drive patient recruitment, source data verification,
drug accountability, data collection), collecting regulatory documentation (when required), performing
qualification, initiation, monitoring and termination of i***estigational sites in accordance with ICH
GCP guidelines.

Key Accountabilities
? Assume the ability to meet the requirements of a CRA I with a high degree of proficiency and
autonomy
? Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual
projects
? Train team members on selected tasks
? Keep manager informed about work progress and any issues to avoid surprises. Requires some
interaction / supervision by Manager or assigned mentor.
? Build relationships with i***estigators and site staff
? Participate in I***estigator 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 CRA Coordinator/GRO Lead
? Attend audits / Regulatory Inspection if requested

Skills
? 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 e***ironment
? Sound presentation skills
? Consultative skills
? Client focused approach to work, 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
Education
? Educated to degree level (biological science, pharmacy or other health-related discipline
preferred), equivalent nursing qualification or other equivalent experience
Language Skills
Competent in written and oral English


Note, this CRA position, an outsourced role to our client, one of the largest global pharma (Fortune 500), you will be daily working in the client's office, we are offering the job growth title(up to Sr. CRA) basing on the working experience. 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。