Description
- Review medical Source documents for accuracy, completeness, as well as medical relevance to the adverse event.
- Complete a listing of missing source documents that can be given to the Safety Associate assigned to collect and request for the study.
- Prepare the CEC packages for the Safety officers review. Send out the completed and signed packages to the CEC once the safety officer has completed their review.
- Conduct internal audits and document review
The target profile we are looking for is someone with a cardiology or medical device background that is preferably an RN/BSN/MD. If they do not have the education, they need to have a specialized background focused on the safety aspect of clinical studies. This is because they are reviewing medical documents on the patients regarding their safety and participation in the clinical study for heart valves and they need to understand the medical documents. It is purely reviewing documents and there is no patient contact. They are also not working at the clinical sites, they are working in Irvine.