Kee Ashley Nichole
BMK Consultants, 1611 Carroll Avenue, #1, Saint Paul, MN 55104, USA.
J Med Pract Manage. 2011 Jan-Feb;26(4):245-7.
The Code of Federal Regulations states that a clinical research investigator is responsible for conducting clinical research in compliance with the signed agreement, investigational plan, and U.S. Food and Drug Administration regulations. In order to meet all the research requirements, the proper research staff is critical. A dedicated, experienced clinical research coordinator is key. The research coordinator represents the investigator when interfacing with the corporate sponsor of the study and the practice staff to ensure that subjects are qualified and that the protocol is followed. Due to the wide range of responsibilities that a clinical research coordinator has, there are three skills that a quality research coordinator must possess: attention to detail, organizational and process understanding, and confidence.
《联邦法规法典》规定，临床研究调查员有责任按照签署的协议、研究计划和美国食品药品监督管理局的规定进行临床研究。为了满足所有研究要求，合适的研究人员至关重要。一名敬业、经验丰富的临床研究协调员是关键。在与研究的企业赞助商和医疗机构工作人员沟通时，研究协调员代表调查员，以确保受试者符合条件并遵循方案。由于临床研究协调员的职责范围广泛，一名优秀的研究协调员必须具备三项技能：注重细节、理解组织和流程以及自信。
