"Clinical Research Nurse"

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 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 related procedures (e.g., determination of causality for adverse events, deviation/exception requests)
• Ensure preparation of all required study related documents for submission to all applicable PENN institutional committees for review and approval to start trial (e.g., IRB, CTSRMC) Participate in SOP development.
• Ensure preparation of study related document templates (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start up.
• Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures. Coordination of apheresis, patient admission, lymphodepleting chemotherapy, T cell infusions, and multiple other procedures (i.e. obtaining tissue biopsies) with multiple departments
• Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events
• Assist with protocol development to ensure logistical feasibility of all study related procedures and study workflow.
• Orient and mentor new unit staff and function as resource for current staff. Assume a leadership role within their
• Working with the CTU and other groups (i.e., radiology department) in developing the process for complicated infusions.
• Other responsibilities delegated as needed.

Qualifications

Bachelor's degree in nursing, Registered Nurse with license to practice in the State of Pennsylvania, 4-5 years of nursing experience and 1-2 years of clinical research experience (total of 5-7 year) combined experience) is required. Oncology and/or cellular immunotherapy clinical trials preferred. Demonstrated capacity/ability from past work experience to learn and apply new concepts, develop skills and knowledge, work/collaborate with others, work independently, organize, prioritize, problem solve and utilize resources appropriately.

The candidate must be a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables. This includes coordination with the clinical team and sponsor teams and providing technical leadership and scheduling for the team to ensure deliverables. Have a thorough knowledge of ICH-GCP regulations and comprehensive understanding of clinical trial processes, and the conduct of clinical studies. Prior Oncology/Immune therapy clinical trial experience preferred.

Excellent communication skills, attention to detail, organizational and time management skills, and the ability to work independently and as a team member are essential qualities for this position. The successful candidate will assure compliance with all applicable regulatory requirements, SOPs, study contracts, etc.