Biobank Biorepository Project Manager
The Molecular Characterization Laboratory (MoCha) is part of Leidos Biomedical Research's Clinical Research Directorate (CRD) at the Frederick National Laboratory for Cancer Research (FNLCR). The MoCha Laboratory is responsible for providing high-level research in support of the NCI-Cancer Diagnostics Program (CDP) within the Division of Cancer Treatment and Diagnosis (DCTD). MoCha is charged with the development and application of genomic assays for use in medical research and diagnostics for DCTD-sponsored national extramural clinical trials.
DCTD and MoCha are jointly responsible for the NCI Cancer Moonshot℠ Biobank program, a new and innovative clinical trial which is intended to accelerate cancer research in key strategic areas that were identified by experts convened in 2016 through a “Blue Ribbon Panel” (https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/blue-ribbon-panel). The strategic areas have in common two core elements: (1) critical scientific and medical questions, the answers to which could rapidly accelerate progress in cancer research, and (2) the need for nationwide participation by a diverse group of research subjects who have agreed to share their biospecimens and/or derived data to contribute to progress in cancer research.
Up to 2,000 longitudinal samples from patients with 10 different cancer types will be collected at Biospecimen Source Sites (BSS) and utilized by researchers studying mechanisms of drug resistance and sensitivity and other important questions. Next-generation sequencing tests will be performed to inform patient treatment decisions. Some samples will be sent to FNLCR for patient derived xenograft model development. A central Biospecimen Core Resource (BCR) will be engaged for sample processing, storage, quality control and distribution. Project data will be uploaded to an NCI designated repository, which provides access to the broader research community.
The Biobank Biorepository Project Manager will work closely with NCI and LBR program leadership and help guide the effort to integrate the BCR in support of the Cancer Moonshot℠ Biobank project.
- Serve as key point of contact between LBR and the BCR regarding all aspects of biospecimen collection based on the Lifecycle of the Biospecimen as defined by the NCI
- Work with key internal and external leads to ensure that both the clinical and research operational needs of the project are being met and help develop and/or revise scientific protocols and procedures as needed
- Work with the IT lead to ensure that clinical and biospecimen data are tracked in the appropriate IT systems and reach public repositories
- Understand the IT systems used to collect and manage the data associated with the project as well as contribute to their design when needed
- Accept input from Quality Assurance for required project metrics, audits, etc.
- Provide regular written reports detailing progress against tasks and milestones
- Work with program leadership to ensure that the budget estimates for projected BCR expenditures are accurate
- Possession of a PhD in a related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) (Additional qualifying experience may be substituted for the required education)
- Foreign degrees must be evaluated for U.S. equivalency
- In addition the education requirements, a minimum of two (2) years progressively responsible experience in program/project management
- Experience developing and/or managing a biobank that is accredited by the College of American Pathologist`s' Biorepository Accreditation Program and follows the International Society for Biological and Environmental Repositories (ISBER) Best Practices for Repositories as well as the NCI's Best Practices for Biospecimen Resources
- Knowledge of IT systems such as a Laboratory Information Management System (LIMS) and data used in biobanks and clinical trials
- Excellent communication and interpersonal skills
- Ability to work globally across organization and with remote sites
- High level of initiative and ability to work independently
- Must be able to obtain and maintain a security clearance
- Experience working in a CLIA lab setting
- A history of membership in the ISBER
- Familiarity with patient and provider engagement strategies for biobanking studies and leading edge informed consenting practices such as electronic consent
- Proficiency with Microsoft Office programs (Word, Excel, PowerPoint, Access, Adobe PDF)
- Highly organized and capable of handling multiple high priority tasks daily
- Ability to communicate effectively, both verbally and in writing with internal and external stakeholders
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)