DescriptionSummary:The Program Manager, Virtual Biobank will be responsible for the overall management, research excellence, upward growth, and rigorous expansion of CHRISTUS Virtual Biobank (CVB), part of CHRISTUS Institute for Innovation & Advanced Clinical Care (CIIACC) under the System Office of Research & Academics (ORA).
This includes planning and implementing strategies to increase availability and utilization of high-quality and fully annotated biospecimen, reduce project costs, and evaluate/deploy new business models.
The successful candidate will serve as a remote manager of daily CVB functions at research site-level for top-notch service delivery, protocol adherence, and regulatory compliance.
S/he will also have a strong background in human subject research compliance and knowledge of applicable federal regulations, as set forth in 45 CFR 46, 21 CFR 56, 21 CFR Part 11, regulatory product development processes, etc.
The incumbent will serve as the subject matter expert of biospecimen research.
S/he will identify, establish, develop, grow business relationships, and attract new research funding from biobank research sponsors, CROs, vendors, academia, government agencies, service providers (such as pathology groups), etc.
Act as a liaison between the System Office, various Regional Research Offices, study sponsors/CROs/vendors, and cross-functional internal/external stakeholdersEnsure timely launch of biobanking projects via feasibility analysis and review, IRB application submissions, budget proposal development, contract/MTA processing, etc.Ensure Research Sites are successfully set-up for daily CVB functions such as screening and ethical consenting of donors, timely biospecimen procurement, processing, labeling, quality control, cold chain management, inspection, packaging, shipping logistics, data abstraction, CRF completion, CTMS compliance, data queries/resolution, invoicing, etc.
Assist and support management in the implementation of system-wide biobanking research protocolsServe as regulatory coordinator for biobanking research projectsMonitor the progress of biobanking research projects throughout the project life-cycleLead remote monitoring, and remote data entryTrack and report metrics, as determined by management, within agreed timelinesDevelop and ensure compliance of reliable Standard Operating Procedures (SOPs) and Policies, as applicableUnderstand, articulate, and implement best practices to ensure highest industry standards for quality controlMaintain confidentiality of personal health information (PHI)Establish strategies for adequate multi-modal marketing of CVB services Requirements: Bachelors degree, preferably in biomedical/scientific discipline, Histology, Medical Technology, or a related fieldOther strong skillsets sought are interpersonal, dependability, leadership, collaboration, organization, multi-tasking, and attention to detail.3 years of experience managing biobank operations, biomedical laboratory, or clinical research operationsExperience with technology systems such as Microsoft Office Suite (Excel, Word, Outlook, PowerPoint), RedCap, LIMS, EMR (EPIC, etc.), EDC systems, CTMS (Credit), etc.Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or obtain within 1 year of employmentWork Type: Full Time