Myeloma Research Program Manager (Cancer Center)
- University of Pennsylvania
- Philadelphia, Pennsylvania
- Director, Researcher
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
Myeloma Research Program Manager (Cancer Center)
Job Profile Title
Manager Research Project B
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 ACC Clinical Research Unit (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 14 Research Teams that support disease/discipline specific cancer programs within the ACC. This Program Manager will have oversight of the ACC CRU- Myeloma Research Team.
The Program Manager position will directly report to the Physician Leader of the Abramson Cancer Center (ACC), Clinical Research Unit (CRU)- Myeloma Research Team and indirectly report to the CRU Central - Associate Director of Clinical Research Operations. The successful candidate will work closely with Physician leader and Lead Research Nurse of this CRU Research Team to oversee all aspects of the clinical research portfolio being performed for their research program. He/she will oversee the start-to-end processes for study start-up and ongoing study management. This includes assisting with study feasibility and selection, prioritization of the team's work, working closely with the CRU Regulatory coordinators to manage, review and initiate trials to ensure competitive activation and enrollment timelines. The Program Manager is expected to actively manage ongoing research projects, troubleshoot operational issues on a daily basis and assist with any and all aspects of their team's work during absences or when a specific team member's workload exceeds capacity (including, but not limited to, managing the research team protocol portfolio including budgets, patient visits, transporting specimens, data entry, query resolution and working with study monitors).
The Program Manager will work closely with major internal (PI, CRU Central - Operations, Regulatory, Education/QA, Budget, Legal, Finance, Billing Compliance, Infusion/CHPS, Investigational Drug Services/Pharmacy) and external (sponsors, facilities, CROs, Subcontractors, Collaborators) stakeholders to develop project plans and support day to day operations of clinical research proposals for their team. The Program Manager will work with Investigators and data informatics teams/programs to ensure the Research Program is supporting the patient population they are studying.
The Program Manager for the CRU will oversee Phase I-IV clinical trials. Additional activities may include recruitment, and enrollment of patients according to protocol requirements for their team. He/she may schedule patient visits and any necessary testing, monitor patients per protocol requirements and ensure adherence to protocol requirements, organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. He/she may collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine and tissue samples, participate in initiation, monitoring, audit and close-out visits, coordinate study team meetings, disease site and/or discipline group meetings, and ongoing protocol training/compliance meetings. The Program Manager will assist in the development/maintenance of study specific case report forms and source document tools, show vigilance in patient safety, protocol compliance and data quality.
Adhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies
Position is Contingent upon Funding
Specific responsibilities include (but are not limited to):
- Supervising the clinical research nurse(s), clinical research coordinator(s), and research assistants for the team. This will include recruiting, interviewing, hiring, training, performance management, and paid time off for the staff. Conduct weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and troubleshooting issues needing to be addressed
- Work with research team physician investigator leaders to ensure balanced staff workload, select and optimize study portfolio for currently available resources in conjunction with available patient population statistics, anticipate any need for the group to hire additional staff based on data analysis and develop a business proposal to reflect any needs
- Work with CRU Central to 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.
- Perform group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572's and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications.
- Work in conjunction with the ACC Budget Specialist, Billing Compliance staff, and Finance office to develop clinical trial budgets. Communicating any specialized study budget needs to the budget specialist, including any changes necessitated by a protocol modification and assisting the financial department by working with the study team to provide study visit information and invoiceable items as needed to the Finance Office.
- Work closely with the Regulatory Coordinators of the CRU to manage review and startup of trials. Submit complete Initial and Amendment study packets and logistical review forms to regulatory, along with appropriate study contacts.
- Work with team members to ensure accurate and timely data entry into electronic Clinical Trials Management System (Velos), including study status, screening logs, serious adverse events and subject enrollment status. The Program Manager may also have primary study coordinator responsibility for at least 1 study.
- Closely monitor and report to their team the status of all studies within their group, including accrual, data entry, query resolution, deviations and patient issues, identifying and addressing any issues
- Collaborate with CRU Central:
- Review of program metrics (performance, portfolio, enrollment)
- Timely communication of significant challenges encountered by the team
- Participate in CRU Central leader meetings and serve on subject matter expert work groups as needed to enhance overall workflow efficiencies and quality of research.
- The candidate will work closely with the CRU Associate Director of Operations to develop and implement SOP's, report team study metrics, and communicate issues that may affect overall research with CRU Trials.
- Perform other duties as may be assigned
POSITION IS CONTINGENT UPON FUNDING
Master's Degree with 3-5 years of related experience or equivalent combination of education and experience is required, related experience in Oncology clinical research experience preferred. And: Bachelor's degree required and 5-7 years of related experience (or equivalent combination of education and experience);
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.
Job Location - City, State
Department / School
Perelman School of Medicine
$59,703.00 - $113,435.00
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.
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
- 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/Myeloma-Research-Program-Manager--Cancer-Center-_JR00043996-1
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