Primary Purpose of Job (Job Summary) 主要工作目标(岗位简介)
The CP Specialist is a science-based position. The primary responsibility of the CP Specialist is to perform research-related and study-related under the guidance of the Clinical Pharmacology Scientist (CPS) or Clinical Pharmacologist (CP). CP 专员是一个以科学为基础的职位。CP 专员的主要职责是在临床药理学科学家 (CPS) 或临床药理学家 (CP) 的指导下进行与研究相关和研究相关的工作。
Principle Roles & Responsibilities / Accountabilities 主要职责/责任
1. Participates in study protocol development, including synopsis, consent form, CRF and amendments. With appropriate experience, the CP Specialist may take the lead in the above tasks under the guidance of the CPS or the CP . 参与研究方案的制定,包括概要、同意书、CRF 和修正案。凭借适当的经验,CP 专家可以在 CPS 或 CP 的指导下领导上述任务
2. Prepares high-quality data analyses and displays for the evaluation of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety, dose/concentration response) from clinical studies
为临床研究的临床药理学数据(药代动力学、药效学、安全性、剂量/浓度反应)的评估准备高质量的数据分析和展示
3. Understand the overall purpose of the designated research work within clinical pharmacology discipline.
了解临床药理学科内指定研究工作的总体目的
4. Conduct high quality data/information collection, analysis performance, outputs preparation and format polish of the research work. 对研究工作进行高质量的数据/信息收集、分析性能、产出准备和格式润色。
These statements are not intended to be an exhaustive list of all responsibilities of the individual assigned to this job, but are instead intended to describe the general nature and level of this work. All above work will be under the guidance of individual’s line manager and equivalent supervisors. 这些陈述并非旨在详尽列出分配给这项工作的个人的所有职责,而是旨在描述这项工作的一般性质和水平。以上所有工作都将在个人的直线经理和同等主管的指导下进行。
Qualification and Experience 能力与经验
Minimum:
• Master, PharmD, PhD, or MD in an area relevant to clinical pharmacology•
与临床药理学相关领域的硕士、药学博士、博士或医学博士
• Appropriate computer software experience (including MS Word, Excel, PowerPoint, etc)
适当的计算机软件经验(包括 MS Word、Excel、PowerPoint 等)
• Working knowledge of various approaches to PK and PD data analysis: compartmental, curve-fitting, non-compartmental. PK 和 PD 数据分析的各种方法的工作知识:房室、曲线拟合、非房室。
• Able to communicate scientific questions in a precise and succinct manner.
能够以准确和简洁的方式传达科学问题。
• Good track record of research work publications
良好的研究工作出版物记录
• Highly effective written communication/ presentation skills in English
高效的英语书面交流/演讲技巧
Desired:
• Experience with advanced data analysis skills (e.g., R or equivalent plotting tools, advanced modeling) 具有高级数据分析技能的经验(例如,R 或等效的绘图工具、高级建模)
• In-depth knowledge of clinical pharmacology and drug development
对临床药理学和药物开发的深入了解
• Highly effective verbal communication/ presentation skills in English•
高效的英语口头沟通/表达技巧