Clinical Research Nurse

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Posted Job Title

Clinical Research Nurse

Job Profile Title

Clinical Research Nurse D

Job Description Summary

The Center for Cellular Immunotherapies (CCI) drives scientific innovation in cellular and gene therapies and fast-track the development of effective new treatments under one umbrella. CCI supports early, high-risk yet promising research and engagement of clinical investigators to conduct early phase trials aimed at learning how the innate and/or adaptive immune system can be used to treat cancer and other diseases.

The Clinical Trials Unit (CTU) is comprised of well-educated and trained personnel who carry out a variety of responsibilities and functions directly related to the execution of clinical trials developed within CCI. The CTU seeks to shift the paradigm for the standards of clinical research in oncology.

Within the Clinical Trials Unit (CTU) in the Center for Cellular Therapies (CCI), the Clinical Research Nurse D will work with various principal investigators to oversee several aspects of the research being performed for their Phase I-Phase II clinical research studies, patient enrollment and follow-up, study monitoring activities, data collection, project maintenance and project close-out activities. The Clinical Research Nurse D will be responsible for performing and/or assisting in the administration of investigational study specified products/medications (i.e., CAR T cell infusions, vaccines). The Research Nurse D will be the principal liaison to ensure effective and timely communication of project progress, issues, and plans for resolution of those issues to both the investigators and sponsor team members.

Job Description

Job Responsibilities

• Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation
• Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policies. AE/SAE reporting for severe toxicities such as CRS, which in some cases results in the patients being transferred to the ICU.
• Coordinate the administration of the investigational product and study related medications including obtaining orders, scheduling administration dates, administration of investigational and study related medications (as applicable), monitoring subjects for post-administration adverse events or reactions. Manages studies that include intraperitoneal, intrapleural and IV T cell infusions. Responsible for independently performing the IV T cell infusions and/or additional investigational products as needed.
• Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of study relate