Clinical Research Nurse D (Center for Cellular Immunotherapy)

Clinical Research Nurse D (Center for Cellular Immunotherapy)

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Employers By State in 2021.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn's vaccine requirements and the use of Penn Open Pass, visit the Penn COVID-19 Response website for the latest information.

Posted Job Title
Clinical Research Nurse D (Center for Cellular Immunotherapy)

Job Profile Title
Clinical Research Nurse D

Job Description Summary
DUTIES:

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.

This position is contingent upon funding.

Job Description

Responsibilities Include:
  • 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 assigned study team.
  • Working with the CTU and other groups (i.e., radiology department) in developing the process for complicated infusions.
  • Other responsibilities delegated as needed.


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.

QUALIFICATIONS:

Bachelor degree in nursing, Registered Nurse with license to practice in the State of Pennsylvania, 3-5 years of nursing experience and 2-3 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.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$59,703.00 - $95,524.33

Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits
  • Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
  • Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
  • Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
  • Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family-whatever your personal needs may be.
  • Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
  • Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
  • Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
  • University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement-and you and your family can enjoy many of these activities for free.
  • Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
  • Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
  • Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
  • Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.



To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay

To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/HUP/Clinical-Research-Nurse-D--Center-for-Cellular-Immunotherapy-_JR00046618-1

Copyright ©2021 Jobelephant.com Inc. All rights reserved.

Posted by the FREE value-added recruitment advertising agency jeid-f1dc56a7dc451047a7b0810f01379d32