Clinical Research Associate in Des Plaines, IL

• 3-5 Years Experience Level
• Member of the clinical team responsible for conducting Diagnostic/IVD clinical trials according to Federal Regulations, GCP and ICH guidelines and study protocol, including but not limited to the following:
  • Planning study conduct 
  • Writing study protocols, informed consent forms (ICF), designing case report forms (CRF) 
  • Assisting with the CRO selection as appropriate, working with the CRO, including training and oversight as appropriate 
  • Assist in selection and training of study site staff as appropriate 
  • Planning and running study meetings as appropriate 
  • Maintain the study trial master files and track study documents 
• Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary.
• Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
• Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines
• Assist with and coordinate initial budget and contract negotiations with study sites or CROs.
• Assist and coordinate with the contributors of the clinical reports and other regulatory documents as appropriate.
• 1-3 Years’ Experience Level at a diagnostic and or laboratory environment, Pharmaceutical or a CRO.
• Familiarity and proficiency with clinical site monitoring (site qualification, initiation, routine monitoring and close out).

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