Clinical Regulatory Coordinator A/B (Center for Cellular Immunotherapy)

Clinical Regulatory Coordinator A/B (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 Regulatory Coordinator A/B (Center for Cellular Immunotherapy)

Job Profile Title
Clinical Research Coordinator A

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.

The Clinical Trials Unit (CTU) is seeking a Clinical Regulatory Coordinator who will support the conduct of clinical trials that are part of the clinical research program at the Center for Cellular Immunotherapies (CCI) and/or sponsored by the University of Pennsylvania or industry sponsored trials. Clinical Regulatory Coordinator will work with various principle investigators to coordinate regulatory submissions for their Phase I-Phase II clinical research studies.

This position is contingent upon funding.

Job Description

Clinical Regulatory Coordinator A:

Bachelor's Degree with 1-2 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required. Some imaging experience is preferred.

Responsibilities will include but are not limited to:
  • Preparation and submission of protocol amendment(s), continuing reviews, and required follow-up until approval is fully granted,
  • Preparation and completion of initial submission of all regulatory documents to the IRB, CTSRMC, and IBC if applicable, including follow-up required to respond to stipulations until full approval is granted,
  • Collaborating with investigators, clinical research coordinators, nurses and managers in preparing and submitting prospective protocol exception requests, and protocol deviations,
  • Collaborating with sponsor representatives, investigators and clinical research personnel for submission of reportable events and all subsequent follow-up until acknowledgement from relevant institutional committees is received and documented
  • Disseminating status information pertaining to initial submission, protocol amendments, continuing reviews, protocol exceptions/deviations, reportable events to key stakeholders for assigned trials - i.e., sponsor representatives, investigators, study personnel and unit managers,
  • Participating in collection and filing of all protocol training and competency records,
  • Participating in generation of memos to file as applicable,
  • Filing of all regulatory correspondences and documents in study site trial master files according to CTU standard of practice and in compliance with federal regulations and guidance, and institutional policies and guidelines,
  • Maintaining regulatory correspondence index for every assigned trial to facilitate good record keeping,
  • Facilitating sponsor-initiated monitoring visits, internal compliance reviews, and site quality audits by scheduling and hosting the visits (if relevant stakeholder) and coordinating responses to all findings related to regulatory activities for the trials,
  • Participating in trial study start-up and close-out activities as a relevant stakeholder (initial submission to all relevant UPenn reviewing committees, collection of financial disclosure forms, completion of Delegation of Authority Log, archiving, etc.)
  • Storing study files in long term storage in compliance with federal guidance, sponsor directives, and departmental standard practice, including maintenance of long-term storage tracker,
  • Participate in regulatory team meetings, sponsor-site monthly meeting, unit staff meetings, and protocol training/compliance meetings,

Clinical Regulatory Coordinator B:

Bachelor's degree and 2-3 years of clinical trial/clinical research experience or equivalent combination of education and experience required.

The Clinical Regulatory Coordinator B will have the same duties as A but will also include the following:
  • This individual will work independently with minimal supervision.
  • Participating in the development of regulatory guidance documents and SOPs
  • May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues.

The candidate must be a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables. 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

Working Conditions:

Office, Library, Computer Room

Physical Effort:

Typically sitting at a desk or table; Occasional lifting 25 lb. or less

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$37,220.00 - $56,087.33
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.

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