北京招聘

职位：CRA-器械

工作地点：亦庄

Job Summary
This position is responsible for supporting site management activity and assisting the maintenance of study documents in order to demonstrate that each study is conducted, recorded and reported in compliance with the protocol, SOPs and applicable regulatory/industry requirements.
Principal Duties and Responsibilities
Perform Quality Control (QC) check and filing to ensure the appropriate clinical research documentation that demonstrate the conduct, recording and reporting of Regulatory studies are in compliance with the protocol, SOPs and Good Clinical Practice (GCP).
Assist with the preparation of study protocol, case report form, informed consent form, clinical study report and other relevant documents required in the conduct of clinical studies.
Ensure that appropriate submissions are made to Ethics Committee of the institutions and all clinical investigational site-specific documentation including clinical trial agreement is approved by relevant parties.
Perform in-house QC check on case report forms and data entry for post-market studies. Participate in site evaluation/initiation/monitoring/closure visits and document appropriately for post-market studies
Coordinate the drafting, review and approval of SOPs and working instructions.
Total Percent (not to exceed 100%)
Expected Areas of Competence (i.e. KSAs)
Good knowledge of GCP and regulations related to clinical studies - some experience in conducting clinical studies under GCP standard is advantageous
Good interpersonal and communication skills
Proficient in reading, writing and speaking of English
Education/ Experience Requirements
University degree above in any Science disciplines (e.g. health science, medical pharmacy or engineering is preferable)
At least five year experience in Clinical Research.
Travel Requirements
Occasional domestic overnight travel is required.

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