Clinical Research Associates (CRAs) - (Strongsville, OH)

Clinical Research Associates (CRAs) The Clinical Research Associate (CRA) from IMARC Research, Inc. will work with a sponsoring company or CRO in the monitoring of device, biologic, and pharmaceutical trials with an emphasis placed on ensuring the highest ethical and clinical standards. The CRA will monitor clinical research sites in accordance with FDA Regulations, GCP compliance, company SOPs, and client guidelines. Monitoring assignments include: Conducting pre-study, initiation, routine (as needed to ensure protocol compliance), and close-out visits; training study coordinators/investigators on protocol including study procedures, CRF completion, enrollment, and informed consent; working with staff at study sites to resolve data discrepancies; obtaining/reviewing/processing of regulatory and administrative documents from investigative sites; maintaining investigational product accountability; monitoring IRB qualifications; and reporting findings from visits.