(高级)临床监查员/(Sr.)CRA

2021-01-20

Position: (Sr.)CRA


Report to: Sr. PM


Location: Beijing/guangzhou/Shandong/Wuhan/Changsha/Chongqing/Chengdu


Position Summary

To collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. To monitor investigator sites in compliance with SOPs, ICH/GCP and local regulations so that site performance targets are achieved and that the company’s image with its external customers is enhanced.

 

DUTIES & RESPONSIBILITIES 

1.     Proactively manage a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met.

2.     Ensure studies are run in line with ICH/GCP, FDA guideline,local regulations and SOPs.

3.     Responsible for all aspects of site management from collaboration on site selection to study closeout.

4.     Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.

5.     Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred.

6.     Identify issues that may impact on the conduct of the study, Inform the PI and site staff of all issues. Agree and develop corrective and preventative actions with PI and site personnel to close all open issues.

7.     Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team. Train site staff on the protocol,protocol amendments and Visen process.

8.     Ensure that data is entered into EDC systems in a timely manner. Conduct SDV and ensure clinical trials data are submitted to data management in a timely fashion. Ensure that data monitored meets target quality standards.

9.     Ensure proper essential documents are in place prior to trial start up and on an ongoing basis throughout the study. Maintenance TMF to ensure audit trail is complete and accurate.

10.Administer investigator site`s payments.

11.   Administer investigator product accountability through physical inventory and records review. Administer trial supplies ordering,dispatch,return and destruction,where applicable.

 

 

KNOWLEDGE AND COMPETENCIES

1.     Bachelor‘s or higher graduate degree,life Science/nursing graduate or equivalent

2.     At least 1 years of clinical monitoring/Site management experience

3.     Proficient in Microsoft Office, especially Excel,Word,PPT

4.     Knowledge of ICH/GCP,relevant international and local regulations relating to Clinical Research

5.     Demonstrated knowledge of clinical trial methodology and the drug development process,related to monitoring clinical trials,ICH/GCP,FDA, or local regulatory environment.

6.     Experience within the Pharmaceutical industry,clinical operations,and project management.

7.     Maintain knowledge and expertise on all relevant SOPs.

8.     Ability to communicate effectively and appropriately with internal and external stakeholders. Identifies and builds effective relationships with customers.

9.     Works independently,Receives instruction primarily on unusual situations. Ability to organize tasks,time and priorities of self and others;ability to multi-task.

10. Demonstrated ability to introduce new ideas and get them implemented.  Effectively overcoming barriers encountered during the implementation of new processes and systems.

11. Experience of working on projects delivering to high quality and tight timelines.






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