Clinical Research Operations Manager (Central) (Cancer Center)

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Clinical Research Operations Manager (Central) (Cancer Center)

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 Operations Manager (Central) (Cancer Center)

Job Profile Title
Manager Research Project C

Job Description Summary
The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The mission of the ACC Clinical Research Unit (CRU) is to advance the science of cancer care, serve our patients by improving clinical outcomes, and offer the best available innovative care to trial participants. The ACC CRU is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 12 Research Teams that support disease/discipline specific medical oncology cancer programs within the ACC. The central Clinical Research Operations Program Manager(s) have direct oversight of the ACC CRU Research Teams.
This Clinical Research Operations Manager position will directly report to the ACC CRU Central - Associate Director of Clinical Research Operations and indirectly to the Physician Leaders of the ACC CRU Research Teams. The successful candidate will work closely with the ACC CRU Research Teams' Program Manager (PM), Lead Clinical Research Nurse (CRN), and Physician Leadership to oversee all aspects of the clinical research portfolio being performed for their Research Team(s).

THIS POSITION IS CONTINGENT UPON FUNDING

Job Description

The Clinical Research Operations Manager is responsible for:
  • In conjunction with the ACC CRU Research Teams' Physician Leadership, provide supervision and performance management for each ACC CRU Research Teams' PMs and Lead CRNs
    • Recruit, hire, and mentor PMs/Lead CRNs
    • Providing frontline day to day clinical research operations leadership
    • Providing functional coverage support for PMs/Lead CRNs
  • Guide each ACC CRU Research Team PMs/Lead CRNs and Physician Investigator Leaders to ensure balanced staff workload, optimize study portfolio for currently available resources, anticipate any need for the research team to hire additional staff based on data analysis, maintain the overall staff assignments and workload for their group, identifying any needs or areas of under-utilization.
  • Closely monitor the status of all studies within their assigned Research Teams, including accrual, data entry, query resolution, deviations and patient issues, identifying and addressing any issues
  • Collaborate with ACC CRU Central Associate Director of Clinical Research Operations:
    • Review of Research Team metrics (performance, portfolio, enrollment)
    • Timely communication of significant challenges encountered by the team
    • The candidate will work closely with the ACC CRU Associate Director of Clinical Research Operations to develop and implement guidance documents, work instructions, report team study metrics, and communicate issues that may affect overall research with ACC CRU Trials.
  • Lead ACC CRU Central PM meetings and serve on subject matter expert (SME) work groups as needed to enhance overall workflow efficiencies and quality of research with collaborators.
  • Work closely with the CRU Regulatory Managers to optimize Regulatory Support for Research Teams
  • Serve as the central liaison to the ACC Budget Specialist, Billing Compliance staff, and Finance office and the ACC CRU Research Teams
  • Function as the primary PM for an assigned ACC CRU Research Team
    • Facilitate the initiation of new trials from feasibility review, new study submission, through activation, including tracking of protocols, contracts, and budgets through the start-up process, working with sponsor to schedule SIV's, and maintain communication with study teams and collaborative UPHS departments regarding progress
    • Oversee the lifecycle of the study
    • Provide direct supervision to the Research Team's clinical research staff (including CRNs, CRCs, RAs, and Data Managers).
  • Perform other duties as may be assigned


Qualifications

Master's Degree and 5-7 year of related experience or an equivalent combination of education and experience required. Oncology clinical research experience preferred. 5+ years of Good Clinical Practices (GCP) related experience required; Thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines. Knowledge of funding policies, NIH, and other grant procedures is desired

THIS POSITION IS CONTINGENT UPON FUNDING

Job Location - City, State
Philadelphia, PennsylvaniaManager Research Project C

Department / School
Perelman School of Medicine

Pay Range
$74,476.00 - $117,086.00
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

To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Clinical-Research-Operations-Manager--Central---Cancer-Center-_JR00047711-1

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