POSITION 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 FUNCTIONS / RESPONSIBILITIES

ACCOUNTABILITIES:

The responsibilities of the6HQLRU 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

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• 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

EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE 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