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Study Start Up Associate / ICD Reviewer

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Study Start Up Associate / Informed consent form document reviewer
 
If informed consent document review is your specialty, then ICON Clinical Research may have the perfect role for you.  This is an exciting opportunity to work within a fast paced, busy study start up clinical group for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a Study Start up Associate you will be responsible for the independent preparation, review and approval of country-related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines. This role is also responsible for the independent preparation, review and approval of site level critical documents for investigation drug release in accordance with regulatory and sponsor requirements. A key responsibility is to develop and finalize the master and country-specific informed consent forms used by the sites and approved by local and central institutional review boards (IRBs) and ethics committees.  You would also be involved in the site start up activity for clinical research, investigative sites.  You would play an important role in ensuring clinical sites are ready for the first day that the drug trial begins. 
 
We are looking for someone who is experienced with study start up activities in a clinical environment and who is responsible to handle a variety of tasks in a short time frame.  You should have knowledge of how an investigative study is run as well as regulatory requirements.  We prefer someone with a bachelor’s degree who is an expert in reviewing informed consent forms and then negotiating language and final terms between the central IRB, local IRBs, and following up with legal as needed in accordance to the study protocol.  
 
Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent retirement plan, private health care, and life insurance, and staff recognition schemes.  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.   
 
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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