Ref #: 26566

Employment type: Permanent - Full-Time

Location: China-Shanghai

Description

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 communication 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 communication 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