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:
· Perform site monitoring visits in accordance with the study Monitoring Plan and ZOLL Standard Operating Procedures to ensure compliance with the Clinical Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and ZOLL standards, guidelines and policies
· Communicate visit findings with site personnel and complete a written follow-up letter for distribution to the Principal Investigator and appropriate site personnel
· Prepare comprehensive site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan
· Identify site needs and propose solutions to facilitate the clinical trial process
· Act as a primary point of contact for study sites as requested
· Provide input into the development and improvement of investigator and site management systems (e.g., CTMS)
· Assist in or conduct initial and ongoing site personnel training as required
· Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures
· Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance.
· Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations, etc.)
· Possess a working knowledge of disease state and investigational product
· Possess understanding of regulatory requirements
· Mentor and/or train junior personnel
· Adhere to all applicable ZOLL policies and procedures