Clinical Research Associate

Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. 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. 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.

Requirements:

• 3-5 Years Experience of Clinical within the industry 
• Bachelor’s degree Required with a preference in  Biological Sciences which fit best BUT “Life Sciences” degrees will also be considered.
• 1 year Medical device experience
• Experience coordinating site initialization and site close
• Familiar with IRB (Institution Review Board) submission 
• ICF (informed consent forms) revision exp.
• Experience editing/revising CRF “case report forms"
• Familiarity with data cleaning and database process (Queries) 
• Basic MS Office with Outlook, Project, PowerPoint and Excel 
• Training PI staff 
• HCI Guidelines 
• “Viva” experience is for electronic filing is preferred