Job Description

Job Description Summary:
GW’s Department of Microbiology, Immunology, and Tropical Medicine (MITM) conducts innovative, fundamental, basic and translational research for HIV/AIDS and neglected conducts innovative, fundamental, basic and translational research for HIV/AIDS and neglected tropical diseases. MITM has a strong tradition of training and policy advocacy for these infectious and parasitic diseases, which initiate and perpetuate poverty and suffering worldwide. Additional information on MITM can be found at the following link: http://smhs.gwu.edu/microbiology/.

The AIDS and Cancer Specimen Resource (ACSR) consists of the Regional Biospecimen Repository (RBR) and the AIDS Malignancy Consortium (AMC) Domestic Biorepository (AMCB). The ACSR also supports the AMC Sub-Saharan African RBR and AMC Biorepository (AMC SSAB) and the Latin American (LATAM) RBR and AMC Biorepository (LATAMB). The Biorepository Supervisor reports to the ACSR Principal Investigator at GW (Silver) and takes daily direction from the Director of the ACSR’s RBVR at GW, who is also the Chair of the AMC Laboratory Resource Committee (LRC) and the Director of the AMC Network Resources Laboratories (NRL) (Bethony).

The Biorepository Supervisor oversees the daily operations of the AIDS and Cancer Specimen Resource (ACSR), with a primary focus on ensuring quality control, quality assurance, and regulatory compliance across all biorepository activities. This includes the management of the AMC Domestic Biorepository, which supports biospecimen processing, storage, and distribution for the AIDS Malignancy Consortium’s clinical trials and correlative studies. The Supervisor ensures that all biospecimen handling and documentation adhere to GCLP standards and that full traceability is maintained through GlobalTrace and other ACSR data systems.

In addition to AMC-related activities, the Biorepository Supervisor assists in the processing of vaccine clinical trial specimens for the Clinical Immunology Laboratory (CIL) on an as-needed basis, coordinating with study teams and overseeing the management of biomaterials within the GW Biorepository Core Facility. Responsibilities may include scheduling and supervising processing activities for both ACSR- and CIL-supported studies, facilitating communication between clinical and laboratory teams, and maintaining adherence to study-specific biorepository manuals of operation.

Through these integrated efforts, the Biorepository Supervisor plays a central role in ensuring that the ACSR’s mission—to provide high-quality, well-annotated biospecimens for HIV and cancer research—is achieved efficiently and in alignment with AMC and NIH expectations.

In general, this position manages, oversees, and organizes the ACSR Biorepository to ensure the efficient running and quality of this NCI-sponsored biobanks operational to meet its responsibilities in support of the UM1 award (ACSR), which includes maintenance of CAP accreditation. This position is responsible for the daily operation of the ACSR.

Manage (i.e., schedule, organize, and evaluate), train, and supervise ACSR team members:
Manage and allocate resources and staff to support biorepository activities
Ensure all personnel adhere to the SOPs and follow the biosafety procedures for handling biospecimens at a BSL2+ level
Oversee staffing and workflow to ensure efficient and accurate achievement of ACSR goals;
Develop, maintain, review, revise, or edit training manual(s), which can include SOPs and BMOPS
Oversee staff required credentials and renewals, including biosafety training and Citi training in Good Clinical Practices
Manage the Clinical Immunology Laboratory blood processing schedule

Quality Management:
Assist the Biorepository Directors in the maintenance/revision of a Quality Management Plan
Design, conduct, and schedule regular quality control tests/audits and reports
Oversee the development of new SOPs and the annual review of SOPs and BMOPs
Assist with the development and be responsible for scheduling and documenting regular reviews of SOPs and BMOPs
Oversee performance of quality control checks and documentation regularly (24/7) to ensure that procedures are consistently followed
Respond to Corrective Action and Prevention (CAPA) reports
Assist in the Preparation of documents and the biorepository for the College of American Pathologists (CAP) accreditation and the annual self-inspection audits
Assist in sending samples for the Immune Quality Assurance program for PBMC proficiency testing

Biorepository Management:
Purchase and maintain adequate quantities of routinely used supplies to ensure operations can proceed with no or minimal disruption
Assist ACSR Directors with budget and purchase of capital equipment
Maintain document control by managing and organizing all project documents (reports, memos, audits, communications, etc.), ensuring their standardization, accuracy, quality, and integrity
Adhere to retention policies, safeguard information, and retrieve data more effectively
Create and update sample management tracking logs and forms
Recognize, document, and resolve protocol deviations
Create estimated budgets for ACSR studies
Verify and authorize specimen requests

Receiving, Processing, and Distribution of Specimens for ongoing clinical vaccine trials as well as samples for correlative studies:
Maintain daily scheduling of processing activities in the biorepository and clinical immunology laboratory for clinical trials
Process whole blood into PBMCs, plasma, and sera according to HANC SOP from ongoing vaccine clinical trials and AMC clinical trials
Ensure Good Clinical Practice, Biorepository Best Practices, and CAP standards are met for samples processed in the biobank
Assist with routine tasks as necessary for vaccine clinical trials Prepare project data analysis and statistics
Assist with FW and GT inventories in collaboration with the Office of Data Management and Coordination (ODMC) of the AMC and the informatics hub for the RBR

Representation and Outreach Support:
Serves on relevant ACSR committees as needed and requested by directors
Participate in outreach activities explaining the purpose, collections, and management of the ACSR at GW, SSAB, and LATAM

Performs other work-related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
Minimum Qualifications:
Qualified candidates will hold a high school diploma/GED plus 4 years of relevant professional experience, or, a Bachelor’s degree or higher in a relevant area of study. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.
Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications:
Preferred Qualifications:
At least one year’s experience in the following:
Processing, inventory, and cryopreservation of biomaterial in support of clinical trials, with an emphasis on Best Practices for Biobanks and Biorepositories
Experience in biobanking research methods (i.e., biospecimen sciences), inventory maintenance, and biobanking informatics, and their routine application to biobanking operations: e.g., maintenance of the inventory, pulling samples, assembling shipments, and receiving shipments
Experience in cryopreservation methods, with a particular emphasis on the isolation and cryopreservation of PBMCs according to the HIV/AIDS Network Coordination (HANC) SOP for isolation and cryopreservation of Peripheral Blood Mononuclear Cell (PBMC) as well as for processing plasma and serum
Processing whole blood from Streck tubes 9or their equivalent) into capture cell-free DNA (cfDNA)
Experience in biorepository informatics and sample tracking systems: e.g., FreezerWorks [FW] and GlobalTrace [GT]
Experience in writing biorepository SOPs, Biorepository Manual of Operations (BMOPs), and reading and understanding clinical trial protocols
Experience in writing and reviewing quarterly and annual biorepository reports on processing, inventory, receiving, and shipping
Experience in shipping using Cryoports or other LN2 shippers
Experience in communicating orally and electronically with biorepository directors, biorepository staff, clinical site staff, and protocols team members, which includes communicating with clinical investigators (e.g., physicians, physician assistants, nurses, and clinical coordinators)