This is an exciting opportunity toworkwithin a fast paced, busy environment for a leading global provider of outsourced development se
rvices to the pharmaceutical, biotechnology and medical device industries.The successful candidate will identify, select, initiate and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs applicable regulations and the principles of ICH-GCP. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
Overview of the Role
Independent and proactive coordination of all the necessary activities required to set up and monitor a study.
Oversee CRA monitoring visit and complete queries generated from visit.
Perform additional quality control checks prior to case report form completion.
Complete closure forms and packaging of source documents and case report forms at the end of assigned study. Review subjects research chart for completion of case report forms.
Complete or facilitate in the completion of sponsor initiated data queries.
Participate in the review of source documents. Participate in internal and external audits as required.
Role Requirements / Skills / Experience Required
Bachelor’s degree, or local equivalent, in medicine, science or related discipline.
Experience should include monitoring skills. Experience should be a minimum of 2 years of active independent field monitoring with intensive PK Phase I studies and site management experience.
Ability to review and evaluate clinical data.
Computer literacy desirable.
Good oral and written communication skills.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.
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.
Clinical Research Associate
US-Any US location
Clinical - Operations
23/Apr/13, 7:16:01 PM
ICON Clinical Research - 11 months ago
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