Clinical Research Associate (Dallas, TX)

The Clinical Research Associate (CRA) position represents an opportunity to grow within an emerging medical device company. Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) / ICH, and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical. The CRA has broad exposure to clinical research tasks as a combination of in-house and field work.

Monitoring Responsibilities :

• Conduct site qualification, initiation, monitoring and closeout visits in accordance with applicable guidelines and client's SOPs and create documentation of such through accurate and detailed visit reports.
• Monitor source documents to EDC for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion / exclusion criteria
• Review all source records for patient safety and ensure complete documentation of all subject safety events.
• Review regulatory binder to ensure complete, accurate, and up-to-date regulatory compliance at the site.
• Ensure compliance with protocol and overall clinical objectives.
• Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks.
• Ensure investigator involvement in the study and IRB / EC oversight.
• Follow-through after visits to see that all outstanding requests / needs are fulfilled.
• Raise issues of significance to the appropriate level for resolution.
• Able to help site navigate informed consent issues and support IRB submission process, as needed.

Site Management & Study Support Responsibilities

Qualifications :