Quality Assurance Nurse - Clinical Trials

Job description

Quality Assurance Nurse - Clinical Trials Position Summary: This position is a very important role within the Cancer Center’s Clinical Trials Department. Under the direction of the Quality Assurance Manager, the Quality Assurance Nurse evaluates patient charts and regulatory documents for compliance and quality assurance. The ideal candidate will be required to both maintain and develop quality assurance processes and procedures, using working knowledge of ICH/GCP requirements along with an understanding for evaluating studies that are Investigator-Initiated, NCI and/or Industry funded. Duties of a Quality Assurance Nurse may include the following but are not limited to: · Demonstrates general knowledge of biological principles and scientific methods. Demonstrates knowledge of regulatory requirements (FDA, IRB, SOPs, GCPs, ICH, etc) by identifying sources of regulatory information, staying current on all new and existing laws, advising staff on regulatory and quality assurance issues, seeking clarification when needed, and conducting training sessions to informs staff of new guidelines/trends. · Under the direction of the QA Manager, and through the internal audit process, the QA N...