As a CRA, you will be specifically responsible for:
- Conducting qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol
- Communicating with the medical site staff, including coordinators, clinical research physicians, and their site staff
- Verifying adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff
- Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are adhered to, and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements
- Ensuring that the investigator is enrolling only eligible subjects
- Reviewing regulatory documents
- Ensuring medical device and/or investigational product/drug accountability and inventory
- Verifying and reviewing adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
- Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement
- Completing monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance
