Clinical Research Coordinator C (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 Large Employers in 2023.
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.
Posted Job Title
Clinical Research Coordinator C (Center for Cellular Immunotherapy)
Job Profile Title
Clinical Research Coordinator C
Job Description Summary
The Center for Cellular Immunotherapies (CCI) drives scientific innovation in cellular and gene therapies and fast-tracks 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.
Clinical Trials Unit (CTU) seeks a full-time Clinical Research Coordinator C to organize, coordinate and implement complex immune therapy oncology clinical trials. This position will report directly to the Associate Director and work directly with Physician Investigators ("PI") on Clinical Research performed. He/she will be responsible for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards.
The Clinical Research Coordinator (CRC-C) is an integral and essential member of the CTU. We are looking for an enthusiastic, professional, and committed team member. The CRC-C will ensure effective and timely communication of project progress, issues, and plans for resolution of those issues to both the investigators, unit managers, and sponsor team members for assigned studies.
Job Description
Responsibilities include but not limited to:

• Coordinate the conduct of complex early phase CAR T-cell clinical trials within CCI-CTU.
• Organize, participate, and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits.
• Be actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reviewing medical records of upcoming new and return patient clinic visits and discussing with investigators, reaching out to potential referring physicians, approaching potential subjects in the office or speaking to them by phone, asking pre-screening eligibility questions, etc.). May participate in the clinic to explain a trial and conduct informed consent with the patient and family.
• Develop, schedule, and oversee participant visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (GCP)
• Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality.
• Participate in the development/maintenance of electronic study specific case report forms and source document tools. Organize and maintain all documentation required by the sponsor per GCP - includes source documentation, case report forms, and research charts.
• Assist in the development of unit Forms/Templates to be congruent with unit GDOs; Participate in GDO development
• May act in a lead capacity.
• Independently manage complex clinical trials.
• Orient/mentor of inexperienced staff and act as resource to current staff members with study related issues

This individual will work independently with minimal supervision. 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 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 of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.

This position is contingent upon funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$51,824.00 - $60,813.00 Annual Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
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