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1.Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
2.Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
3.Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
4.Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead ( CTL ) and/or line manager.
5.Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
6.Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
7.May provide assistance to less experienced clinical staff.
1.Bachelor''s degree with major in medicine or pharmacy science. Master''s degree is a plus.
2.Min 2-3 year(s) working experience in clinical research and monitoring. Less experience will be considered as CRA Trainee;
3.Basic knowledge of, and skill in applying,applicable clinical research regulatory requirements; i.e.,Good Clinical Practice (GCP) and International Conference on Harmonisation ( ICH ) guidelines;
4.In depth therapeutic and protocol knowledge as provided in company training;
5.Excellent verbal and written communications skills in both Chinese and English languages;
6.Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer;
7.Excellent organizational and problem-solving skills;
8.Effective time management skills;
9.Ability to manage competing priorities;
10.Willing to travel frequently.
Quintiles Transnational Corp. helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Quintiles helps its customers compress the time it takes to bring a drug from discovery through regulatory approval; accelerate the launch of products to peak sales, build effective sales forces and manage product portfolios more efficiently; and achieve strategic and financial objectives by offering tailored alternatives to traditional fee-for-service product development and commercial services agreements. Headquartered near Research Triangle Park, North Carolina, Quintiles was founded in 1982 and has more than 16,000 employees and offices in over 50 countries. Quintiles Medical Development (Shanghai) Co., Ltd. is a wholly owned subsidiary of Quintiles Transnational Corp. Due to the rapid expansion of our business in China, we are seeking qualified candidates for the positions.
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