Biospecimen Liaison

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Job description

Biospecimen Liaison

Job ID: req4108
Employee Type: exempt full-time
Division: Vaccine, Immunity and Cancer
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

The Vaccine, Immunity and Cancer Directorate investigates immune responses to vaccines in preclinical and clinical studies, with a focus on HPV and more recently on SARS-CoV-2. As part of a large effort to combat the current SARS-CoV-2 pandemic, the National Cancer Institute (NCI) is collaborating with the National Institute of Allergy and Infectious Disease (NIAID), the Centers for Diseases Control and Prevention (CDC), the Food and Drug Administration (FDA), the Frederick National Laboratory (FNL) and other stakeholders to develop assays with the highest reproducibility, sensitivity, and specificity for evaluation of immune responses against this new virus. To address gaps and unmet needs in serology assay development and standardization and to gain a solid fundamental knowledge of the immune response to SARS-CoV-2 and underlying mechanisms of protection against infection, NCI has established the Serological Sciences Network (SeroNet), which includes the Frederick National Laboratory (FNL) Serology Lab, leveraging the vast expertise and excellence in HPV serology at the FNL.

The Center of Excellence for Serology Development and Emergency Preparedness (CESDEP) provides both a more targeted and global response to the evolution of SARS-CoV-2, requiring innovative thinking, outreach and partnership with global leaders. CESDEP will leverage and deploy the knowledge from existing program to bring high quality, precision biomarker assays to help combat SARS-CoV-2 in those most vulnerable, particularly in cancer, HIV, and immunocompromised individuals.

KEY ROLES/RESPONSIBILITIES

The Biospecimen Liaison provides biospecimen program and operation support for the Center of Excellence for Serology Development and Emergency Preparedness (CESDEP). Works directly with Laboratory Manager and the staff to provide laboratory support, shipping, receiving and aliquoting (as needed) of biospecimen samples, coordination of samples with external centers and internal team including establishing legal mechanisms for material transfers, and as required. Also assist with administrative, procurement, facilities, inventory and equipment maintenance and records, routine lab assays and any other support in CESDEP as needed. Knowledge of human research subject regulations a plus.

Specific duties will include:

• Assists with overall coordination of biospecimen repository program functions including receiving, shipping, packing, handling with internal and external facilities
• Modifies and prepares Material Transfer Agreements for individual requests
• Collaborates with Legal office for Material Transfer Agreements
• Follows all GCLP requirements for all assigned and unassigned duties
• Prepares, schedules and ships reagents domestically and internationally
• Coordination with FNL repository for incoming and outgoing shipments
• Maintains inventory of packing materials, dry ice, etc. for shipments
• Updates reagent inventory and databases
• Support reagent preparation for testing
• Support laboratory assays as required
• Maintain lab equipment and reagent records (SDS) as per GCLP compliance mandates
• Electronically tracks, stores and updates data and information
• Perform, collaborate, or assist with LIMS (lab information management system) development and validation for relevant laboratory processes
• Assist with SOP development and implementation
• Preparation of meeting slides for the program as required
• Assist in the preparation of program reports, not limited to monthly quarterly reports, semi-annual and annual reports
• Assist in the development of oral presentations and meetings
• Assist with administrative functions including supply ordering, coordinating work orders, and equipment inventory and maintenance
• Document control tasks for standard operating procedures, forms, controlled documents and laboratory notebook issuance
• Perform other duties as assigned

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of Bachelor's degree in Biology, Public Health or a related field from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirement, a minimum of two (2) years of laboratory experience is required
• Proficient with Windows and MS Office including Word, Excel, PPT
• Knowledge of the use of proper English/grammar/spelling/punctuation
• Ability to effectively maintain files and active records
• Must be able to work fully onsite and in a lab environment with no telework option
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Possession of Master's degree in related field
• Project Management Professional (PMP) license
• Familiarity with immunology, immune assays, diagnostics, vaccines and clinical research
• Familiarity with human research subject requirements and regulations
• Laboratory experience in biomedical science
• Experience with specimen handling and biorepository management
• Experience with LIMS
• Strong organizational and communications skills
• Proficient in Excel with macros, pivot table, formulas and functions
• Agile, team oriented and adaptable to changing priorities to achieve team goals.
• Ability to work in a fast-paced team and multi-task to achieve milestones within deadlines
• In addition to a commitment to excellence in operations, the position requires leadership skills and commitment to the mission

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, color, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law.

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