Research- LPN

GENERAL DESCRIPTION

The primary responsibility of the research nurse is to assist in the management of conducting clinical trials / research studies. The research nurse is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. In collaboration with the study coordinator, the research nurse will act as liaison between principal investigator, sub-investigators, primary care physicians, and the institutional review board (IRB) and the sponsor. Along with the principal investigator, the research nurse will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are in the study. In addition, the research nurse is responsible for data and source documentation, and adverse experience reporting. The research nurse is required to be familiar with the regulatory files and be able to locate information and documents as needed. The research nurse will work under the supervision and direction of the study coordinator and principal investigator. In addition, He / she will report to the study coordinator for day-to-day activities.

1. Sound conduct of the clinical trial, including but not limited to recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol requirements (e.g., subject follow-up, case report form completion, and reporting of adverse drug experiences).
2. Maintenance of accurate and complete documentation, including but not limited to signed informed consent forms and process sheets, source documentation, subject logs, and study-related communication.
3. Organization in performing assigned work, including but not limited to timeliness in completing projects, neatness of work performed, and success in managing multiple tasks.
4. Organizational management of all aspects of the trial, including but not limited to timeliness in completing case report forms, query resolution, data entry, reporting adverse drug experiences or other adverse events, managing case load and managing study subject files.
5. The study nurse will communicate protocol-related questions or problems to the study coordinator / PI (as indicted).
6. Communication of all protocol-related issues/problems to the appropriate management staff (coordinator/ PI), including but not limited to questions regarding the conduct of the clinical trial, and concerns regarding possible AEs or subject compliance.
7. Professional conduct in the presence of subjects, research staff, sponsors, monitors, etc.