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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 Operations Manager, Abramson Cancer Center Clinical Research Unit
Job Profile Title
Clinical Research Program Manager 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).
Job Description
Job Responsibilities
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
Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations. And:
Master's Degree and 5-7 year of related experience (or equivalent combination of education and experience) preferred; or Bachelor's Degree required and 7-10 years of related experience. 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.
Contingent upon grant funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$74,476.00 - $106,940.00 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.
Compensation Information:
$74476.0 / Yearly - $74476.0 / Yearly
Starting At: 74476.0 Yearly
Up To: 106940.0 Yearly
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