ACC CRU Biospecimen Program Manager (Cancer Center)
ACC CRU Biospecimen Program Manager (Cancer Center)
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.
Posted Job Title
ACC CRU Biospecimen 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.
The ACC CRU Biospecimen Central Lab is a centralized laboratory that processes and manages blood, plasma, tissue and other biological specimens obtained from patients enrolled to Oncology Clinical Trials. The ACC CRU Biospecimen Central Lab currently supports 12 ACC CRU Research Teams that are based in the Perelman Center for Advanced Medicine (PCAM) under the direction of the Biospecimen Program Manager. Analysis of biospecimens is essential to the scientific mission of the ACC CRU, which provides support to roughly one-half of oncology clinical and translational research at Penn. This requires adherence to institutional and protocol mandated lab practices. The Biospecimen Preparations and Processing Operations span over 4 different locations in PCAM.
The successful candidate will work closely with Program Managers of the ACCCRU Research Teams to oversee aspects of the study start-up and ongoing study management, which includes assisting with study feasibility relating to Biospecimen Operations. The Biospecimen Program Manager is expected to actively manage ongoing LabVantage (electronic laboratory information management system) activities, 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.
The Biospecimen Program Manager will work closely with major internal (PI, PMs, ACC CRU Central - Operations, Regulatory, Education/QA, Budget, Legal, Finance, Billing Compliance, Infusion/CHPS,) and external (sponsors, facilities, CROs, Subcontractors, Collaborators) stakeholders to develop project plans and support day to day operations of clinical research trials being conducted in the ACC CRU Biospecimen Central Lab.
The Biospecimen Program Manager must adhere to the requirements of the University of Pennsylvania, Perelman School of Medicine, GCP, FDA, OSHA, EHRS and all applicable laboratory standards.
Position contingent upon funding.
Specific responsibilities include (but are not limited to):
- Supervising the Assistant Manager- Biospecimen Lab Operations, biospecimen coordinators and research assistants. 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 unit and operational updates, items that are outstanding, and troubleshooting issues needing to be addressed
- Provide essential emergency off-hours coverage in the event of any threat to specimen integrity such as freezer malfunction.
- Work collaboratively with Program Managers and Study teams to appropriately resource clinical trials by reviewing laboratory manuals and protocols to ensure study feasibility and resolve any logistical issues prior to study activation.Actively participate in Site Initiation Visits and provide training to Biospecimen Staff.Provide additional training/re-training as necessary and in accordance with institutional or study related updates.
- Provide audit preparation assistance to Study Teams by compiling biospecimen records of sample processing, storage and shipment, as well as equipment calibration and maintenance records.
- Work with AD of Clinical Research Operations and Biospecimen Team to develop best practices with the goal of seamless and efficient flow of biological specimens from collection through storage and/or shipment.Oversee LabVantage (electronic laboratory information management system) activities inclusive of new clinical trials, ongoing study updates, and kit inventory storage to maximize utilization of laboratory space and allow for real time assessment of inventory. Work with Biospecimen staff and Study teams to coordinate the removal, disposal, or repurposing of expired or unused laboratory kits and materials
- Develop and regularly update laboratory SOPs, Work Instructions, and best practices to maximize lab efficiency, safety, protocol compliance and adherence to local, state, and federal standards/regulations (GCP, FDA, OSHA, EHRS). Ensure visibility of safety information and chemical hygiene plans within the laboratory spaces, manage and organize lab, study, and staff related documents (i.e. training documentation, equipment purchasing and maintenance records, etc.).
- Oversee laboratory equipment by ensuring proper purchasing, calibration, and performance maintenance.
- Develop and maintain collaborative relationships with internal PSOM, University and Penn Medicine Departments such as Pathology and Laboratory Medicine, Center for Human Phenomic Science (CHPS), Tumor Tissue and Acquisition Biospecimen Bank.
- Work in conjunction with the ACC Budget Specialist, Billing Compliance staff, and Finance office to support the development clinical trial budgets related to biospecimen operations.Communicating any specialized study budget needs to the budget specialist and Program Managers.
- Collaborate with ACC CRU Central Leaders:
- Review of program metrics (performance, portfolio, study lab visits).
- Timely communication of significant challenges encountered by the team.
- Participate in ACC 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 ACC CRU Associate Director of Clinical Research Operations to develop and implement SOP's, and communicate issues that may affect overall research with ACC CRU Trials.
- Perform other duties as may be assigned.
Bachelor's degree and 5-7 years of related experience or equivalent combination of education and experience required. Master's Degree and 3-5 years of related experience preferred. Oncology clinical research and biospecimen processing experience preferred
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
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