School of Medicine:

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DHVI Accessioning Unit Manager

Lab Research Analyst, Senior

OVERVIEW:

The Duke Human Vaccine Institute (DHVI) Accessioning Unit is a multipurpose unit that has three different functions:

1. Receipt, accessioning, processing, and storage of fresh and frozen human and non-human primate specimens.
2. Maintenance of DHVI Biorepository – a biorepository containing ~800,000 samples stored in multiple cold storage units at -20°C, -80°C, and -180°C.
3. Accessioning Unit Core – a DHVI and Duke Shared Resource that is responsible for the processing, storage, retrieval, and shipping of specimens obtained from human clinical studies that fall within DHVI’s mission of performing research against infectious diseases that impact global health.

The DHVI Accessioning Unit operates in a Good Clinical Laboratory Practice (GCLP) environment; procedures and processes follow Standard Operating Procedures (SOPs). Certain aspects are monitored and audited by Quality Assurance for Duke Vaccine Immunogenicity Program (QADVIP). The DHVI Accessioning Unit Manager will report directly to the Senior Laboratory Manager under the leadership of Dr. Tony Moody, Principal Investigator (PI).

RESPONSIBILITIES:

1. Directly responsible for the day-to-day activities of the DHVI Accessioning Unit, including operational and technical aspects, reagent and material inventories, safety, regulatory, and training compliance, and staff management.
2. Directly responsible for samples contained in the DHVI and CIVICs Biorepository; this includes 24/7/365 oversight of all cold storage units housing these samples.
3. In support of the CRIED program, review and analyze biospecimen processing and storage SOPs from multiple labs, identify gaps, and help coordinate synergy between multiple labs.
4. Monitor all technical and operational aspects of the DHVI Accessioning Unit, identifying potential risks and developing proactive solutions. Report all issues to appropriate safety, laboratory, and leadership staff in a timely manner. Take ownership to gain resolution. Regularly update staff of necessary changes in policies/procedures at designated team meetings.
5. With the guidance of the Director, Senior Laboratory Manager, and Program Management, understand project plans and scope and ensure all AU orders are appropriately applied to relevant fund codes. Prepare justifications for purchases, as needed. Assist with reconciling invoices and charges, as needed.
6. Directly responsible for performance management, development, and training of all Accessioning Unit staff. Conduct annual reviews, ad hoc reviews, and design a development plan for each staff member.
7. Delegate appropriate staff to receive, process, and store samples on a daily, weekly, and monthly basis. Ensure staff are appropriately trained, following current SOPs and using appropriate sample tracking databases. Ensure the procedures followed comply with the specific program for received samples (CHAVI-ID, CIVICs, HVTN, VTEU, and Accessioning Unit Core).
8. Prepare monthly and annual technical reports reflecting volume of work, procedures utilized, staff hours required, and results; coordinate the preparation of reports and analyses setting forth progress, adverse trends, and appropriate recommendations or conclusions.
9. Work closely with Senior Laboratory Manager to ensure the Accessioning Unit Core is functioning as a Duke Shared Resource in support of DHVI’s mission.
10. Work closely with the Specimen Database Manager on the search and retrieval of samples stored in the Specimen Database. Review tracking and sample disposition with the Specimen Database Manager to ensure samples are distributed appropriately and within timeline metrics; revise metrics as necessary.
11. Working closely with QADVIP and the Senior Laboratory Manager, annually renew and amend current SOPs and procedures. Review and understand current technologies and field research available in literature to refine SOPs and procedures.
12. Working closely with QADVIP and the Senior Laboratory Manager, prepare the Accessioning Unit for any internal and/or external audits.
13. Perform other duties as assigned by the PI and Senior Laboratory Manager.

MINIMUM REQUIREMENTS:

Education/Training: Work requires a bachelor's degree in botany, biology, zoology, psychology or other directly related scientific field.

Experience: Work requires five years of research experience. A related master's degree may offset required years of experience on a 1:1 basis, e.g., a two year master's degree in lieu of two years of experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

PREFERRED REQUIREMENTS:

Minimum Masters level degree in health or physical sciences. Minimum of 3 years of relevant experience managing a scientific laboratory or clinical specimen repository. Must have proven organizational skills, communication skills, and proficiency in Microsoft Excel, Word, and PowerPoint, as well as LIMS entry. Must be comfortable providing written and oral updates to multiple levels.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.