The Clinical Research Data Monitor (Field CRA) will work as a Field Clinical Research Data Monitor with focus on US IDE Pre-Market and Post Market trials as a Field Data Monitor with an emphasis placed on ensuring the highest ethical, clinical, and regulatory standards, IRB/EC policies and procedures as well as Business requirements.
The Field CRA will monitor clinical research sites in accordance with FDA Regulations, GCP compliance, company SOPs, company guidelines and ZOLL’ clinical study protocols. Monitoring responsibilities include: conducting pre-qualification visits, site initiation visits, interim monitoring visits (as needed to ensure protocol compliance), and close-out visits; training study coordinators and 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 requirements; and reporting findings from visits. Travel is approximately 50 – 75% to study sites and meetings. International travel may be required.
Job Function Description:
Equal Opportunity Employer – Disability and Veteran