Cherokee Federal
Senior Biospecimen Manager
Cherokee Federal, Silver Spring, Maryland, United States, 20900
Senior Biospecimen ManagerAs required by our governmental client, this position requires being a US Citizen.Our client’s mission is to conduct biomedical research that delivers life-saving products including knowledge, technology, and medical materiel. Their efforts include the development of medical countermeasures capable of protecting and sustaining human health.Their focus is on understanding viral diseases threatening the Fighting Force and Global Health domestically and abroad. The research programs include dengue, influenza, adenovirus infections, and other emerging and re-emerging viral diseases such as chikungunya virus and hepatitis C virus. Infectious disease syndromes caused by existing, emerging, or re-emerging viral pathogens, not otherwise identified, is also an area of research. Research includes disease surveillance and sample collection, basic and exploratory science, translational research, and product research and development, licensing, and medical countermeasures. The environment is comprised of onsite fully equipped and operational laboratories, freezers with active biospecimens, and offices; as well as biospecimen shipping and receipt of samples and materials.Compensation & Benefits:Estimated Starting Salary Range for
Senior Biospecimen Manager : $75,000 - $90,000. Pay is commensurate with experience. Full-time benefits include Medical, Dental, Vision, 401K, and other possible benefits as provided. Benefits are subject to change with or without notice.Senior Biospecimen Manager Responsibilities Include:Must have capability to fully own and execute the day-to-day technical and compliance responsibilities and requirements.Fully leads Freezerworks implementation.Leads specimen inventory management training initiatives, as needed.Serves as technical liaison/POC to internal and external entities (i.e., IT department, software vendor) supporting specimen inventory management systems.Actively assists in maintaining software certification of net worthiness, as needed.Stores and retrieves samples from refrigerators (4°C) and freezers (-20°C, -80°C, liquid nitrogen).Logs-in samples, reagents, and materials with barcode scanner or other methods, as applicable.Retrieves and issues reagents and materials to laboratories, as applicable.Maintains accurate documentation and database records to track samples, reagents, and materials in/out.Coordinates and performs shipping and receiving activities related to samples, materials, reagents in accordance with applicable procedures and regulations.Provides logistical support (sample management, data management, storage equipment maintenance, label generation, technical solutions).Co-manages a large repository of samples with round-the-clock surveillance (on-call) to ensure accountability and integrity of critical components and point of contact on environmental monitoring system (DataTron, Freezerworks) call list to respond to alarm events in accordance with applicable procedures.Facilitates transfer and retrieval of samples, under strict cold-chain protocol to and from off-site repository location.Generates summaries and reports to inform management of inventory statuses.Validates and reformats data to customized requirements for submission to clinical trial sponsors/collaborators.Maintains integrity of electronic subject information per HIPAA and Human Subjects Protection (HSP) guidelines.Actively assists in the development of systems and Standard Operating Procedures for data backup and disaster recovery and sample management, or other processes, procedures, and compliance requirements.Writes/edits Study Specific Procedures for projects, as needed.Ensures all database inventories accurately reflect physical sample/material/reagent inventories.Conducts periodic (physical and electronic) inventory reviews and reconciliations.Uses/navigates DataTron, or other environmental monitoring systems to ensure that storage units are operating within specified environmental parameters.Successfully completes shipping certification training and test and ships and receives specimens on behalf of customer Command.Assists with special VDP and Command initiatives.Assists with site visits and inspections.Partners with the Compliance Manager, Laboratory Manager, Program Manager, Laboratory personnel and Scientist, and our government customers, to ensure all requirements are met.Performs other job-related duties as assigned.Senior Biospecimen Manager Experience, Education, Skills, Abilities requested:Bachelor’s degree in life sciences, or related/similar, 5-7 years of relevant work experience in laboratory environment with direct handling and tracking of specimens.Must be able to work with dry ice and ultra-cold temperatures (i.e., -80°C and liquid nitrogen).Familiar with GxP regulations and experienced working in a regulated environment.Ability to receive and handle alarm calls/texts from environmental monitoring system.Ability to travel to job site after-hours, weekends, or holidays may be required as part of the response.Meticulous, detail-oriented, and capable of maintaining focus while performing repetitive tasks.Ability to work independently and in a team environment.Demonstrated ability to multi-task and possess solid time management skills.Possess strong verbal and written communication skills; demonstrate ability to organize vast amounts of data.Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.Ability to lift up to 50lbs.Proficient with Microsoft Word, Excel, Access, and PowerPoint.Excellent written and verbal communication.Must be proficient with inventory and labeling software applications used to manage sample inventory (e.g., FreezerWorks or similar inventory database).Demonstrated skills in laboratory environment and handling biological (potentially infectious) samples.Certified (or able to acquire certification) to package and ship biological materials (including Dangerous Goods).Ability to pass a U.S. Government security investigation and must meet eligibility requirements.Must pass pre-employment qualifications of Cherokee Federal.Company Information:Cherokee Nation Integrated Health (CNIH)
is a part of Cherokee Federal – the division of tribally owned federal contracting companies owned by Cherokee Nation Businesses. As a trusted partner for more than 60 federal clients, Cherokee Federal LLCs are focused on building a brighter future, solving complex challenges, and
serving
the government’s mission with compassion and heart. To learn more about
CNIH , visit cherokee-federal.com.#CherokeeFederal #LICherokee Federal is a military-friendly employer. Veterans and active military transitioning to civilian status are encouraged to apply.
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Senior Biospecimen Manager : $75,000 - $90,000. Pay is commensurate with experience. Full-time benefits include Medical, Dental, Vision, 401K, and other possible benefits as provided. Benefits are subject to change with or without notice.Senior Biospecimen Manager Responsibilities Include:Must have capability to fully own and execute the day-to-day technical and compliance responsibilities and requirements.Fully leads Freezerworks implementation.Leads specimen inventory management training initiatives, as needed.Serves as technical liaison/POC to internal and external entities (i.e., IT department, software vendor) supporting specimen inventory management systems.Actively assists in maintaining software certification of net worthiness, as needed.Stores and retrieves samples from refrigerators (4°C) and freezers (-20°C, -80°C, liquid nitrogen).Logs-in samples, reagents, and materials with barcode scanner or other methods, as applicable.Retrieves and issues reagents and materials to laboratories, as applicable.Maintains accurate documentation and database records to track samples, reagents, and materials in/out.Coordinates and performs shipping and receiving activities related to samples, materials, reagents in accordance with applicable procedures and regulations.Provides logistical support (sample management, data management, storage equipment maintenance, label generation, technical solutions).Co-manages a large repository of samples with round-the-clock surveillance (on-call) to ensure accountability and integrity of critical components and point of contact on environmental monitoring system (DataTron, Freezerworks) call list to respond to alarm events in accordance with applicable procedures.Facilitates transfer and retrieval of samples, under strict cold-chain protocol to and from off-site repository location.Generates summaries and reports to inform management of inventory statuses.Validates and reformats data to customized requirements for submission to clinical trial sponsors/collaborators.Maintains integrity of electronic subject information per HIPAA and Human Subjects Protection (HSP) guidelines.Actively assists in the development of systems and Standard Operating Procedures for data backup and disaster recovery and sample management, or other processes, procedures, and compliance requirements.Writes/edits Study Specific Procedures for projects, as needed.Ensures all database inventories accurately reflect physical sample/material/reagent inventories.Conducts periodic (physical and electronic) inventory reviews and reconciliations.Uses/navigates DataTron, or other environmental monitoring systems to ensure that storage units are operating within specified environmental parameters.Successfully completes shipping certification training and test and ships and receives specimens on behalf of customer Command.Assists with special VDP and Command initiatives.Assists with site visits and inspections.Partners with the Compliance Manager, Laboratory Manager, Program Manager, Laboratory personnel and Scientist, and our government customers, to ensure all requirements are met.Performs other job-related duties as assigned.Senior Biospecimen Manager Experience, Education, Skills, Abilities requested:Bachelor’s degree in life sciences, or related/similar, 5-7 years of relevant work experience in laboratory environment with direct handling and tracking of specimens.Must be able to work with dry ice and ultra-cold temperatures (i.e., -80°C and liquid nitrogen).Familiar with GxP regulations and experienced working in a regulated environment.Ability to receive and handle alarm calls/texts from environmental monitoring system.Ability to travel to job site after-hours, weekends, or holidays may be required as part of the response.Meticulous, detail-oriented, and capable of maintaining focus while performing repetitive tasks.Ability to work independently and in a team environment.Demonstrated ability to multi-task and possess solid time management skills.Possess strong verbal and written communication skills; demonstrate ability to organize vast amounts of data.Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.Ability to lift up to 50lbs.Proficient with Microsoft Word, Excel, Access, and PowerPoint.Excellent written and verbal communication.Must be proficient with inventory and labeling software applications used to manage sample inventory (e.g., FreezerWorks or similar inventory database).Demonstrated skills in laboratory environment and handling biological (potentially infectious) samples.Certified (or able to acquire certification) to package and ship biological materials (including Dangerous Goods).Ability to pass a U.S. Government security investigation and must meet eligibility requirements.Must pass pre-employment qualifications of Cherokee Federal.Company Information:Cherokee Nation Integrated Health (CNIH)
is a part of Cherokee Federal – the division of tribally owned federal contracting companies owned by Cherokee Nation Businesses. As a trusted partner for more than 60 federal clients, Cherokee Federal LLCs are focused on building a brighter future, solving complex challenges, and
serving
the government’s mission with compassion and heart. To learn more about
CNIH , visit cherokee-federal.com.#CherokeeFederal #LICherokee Federal is a military-friendly employer. Veterans and active military transitioning to civilian status are encouraged to apply.
#J-18808-Ljbffr