南京招聘

POSI TION SUMMARY

Identify, select, initiate and close-out appropriate investigational sites for clinical studies. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with related SOP, applicable regulations and the principles of ICH –GCP and with applicable regulatory requirement.

The monitor has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source

documents.

JOB FUNCTIO NS / RESPONSIBILI TI ES

ACCOUNTABILITIES:

The responsibilities of the Senior Clinical Research Associate include, but are not limited to:

？         Act as the main line of communication between the sponsor and the investigator

？     Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout

？         Responsible for the safety and proper conduct throughout the trial

？         Verifying that the investigator follows the approved protocol and all GCP procedures

？     Verifying that source data/documents and other trial records are accurate, complete, and maintained

？     Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs

？     Experience should include monitoring skills. Prior relevant active independent field monitoring experience and site management experience

？         Strong knowledge in ICH-GCP

？         Ability to review and evaluate clinical data

？         Computer literacy desirable

？         Professional use of the English language; both written and oral

？         Good oral and written co***unication skills

？         Due to the nature of this position it may be required for the employee to travel

？         Bachelor degree, or local equivalent, in medicine, science or related discipline

COMPETENCIES

？     Interpersonal skills: open communication, convincing, independent, responsible, sensitive consciousness

？         Management skill: planning and organizing, coordinating, problem solving, organizing

？         Professional skill: accurate, high profile

EDUC ATION, EXPERIENCE, SKILL S AN D KNOWL EDGE REQUIREMENTS

QUALIFICATIONS, EXPERIENCE & SKILLS

？     Experience should include monitoring skills. Prior relevant active independent field monitoring experience and site management experience

？         Strong knowledge in ICH-GCP

？         Ability to review and evaluate clinical data

？         Computer literacy desirable

？         Professional use of the English language; both written and oral

？         Good oral and written co***unication skills

？         Due to the nature of this position it may be required for the employee to travel

？         Bachelor degree, or local equivalent, in medicine, science or related discipline

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.