CRA II

The CRA will be responsible for identifying, selecting, initiating and closing-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.

8 to 9 monitoring visits per month.

Key Responsibilities 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;

Requirements and Qualifications:

·         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;

·         Fluent Professional use of the English language; both written and oral;

·         Good oral and written communication skills;

·         Due to the nature of this position it will be required for the employee to travel;

·         Bachelor degree, or local equivalent, in medicine, science or related discipline.

What’s Next?

Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.