Clinical Research Manager
|Job Title:||Clinical Research Manager|
|Contact Name:||Cherry Zhu|
|Job Published:||March 13, 2020 17:50|
Effectively manage the Clinical Research Center in operation, education, training, and quality control. Supervises, plans, coordinates, and evaluates the management of clinical research studies and relevant operating systems.
Essential Job Function
* Lead the effective operation of clinical research activities as designated by the Director of Clinical Research Office in collaboration with principal investigators or study sponsors; identify problems or obstacles in the system/procedures related to the implementation of research protocols and communicate to the study investigator(s); provide overall coordination and facilitation of clinical research activities to ensure patient safety and data integrity.
* Assist in the development of study budget and negotiation of study agreement; coordinate the protocol administration including initial protocol submission, subsequent protocol revisions, closure, and termination; communicate closely with the IRB office and ensure timely regulatory reporting and distribution of IRB directives.
* Supervise the study conduct and evaluate staff workload and assignment to ensure compliance with protocol requirements, regulations, GCP, institutional policies, and quality measures.
* Set performance expectations for all subordinates and is responsible for hiring, development, coaching, evaluating, and disciplining of all assigned staff.
* Utilize quality improvement tools and statistical process control to facilitate the improvement of clinical research systems and processes.
* Coordinate, plan, and develop training programs for professional and ancillary staff on research protocols, policies and procedures.
* Other duties as assigned by the Director of Clinical Research Office.
Received: Director of Clinical Research Office or designee
Given: Assigned staff
Bachelor of Medicine, Bachelor of Surgery (MBBS), or Bachelor degree in other healthcare-related professions
* Minimum of 5 years in clinical practice including a minimum of 2 years in clinical research and a minimum of 1 year in supervision or a research administration role
* Experience in initiating and development of new research unit/service is preferred
* May substitute required years of supervisory experience with additional years of equivalent experience on a one to one basis.
Licensure and Certification
* Active medical license, nursing license, or other healthcare-related professional licenses to practice in China is preferred
* GCP Certification/证书
* Excellent written and oral communication skills
* Fluent in Mandarin Chinese and English