Supervisor, Clinical Trial Specimen Lab (req1985)

Company: Frederick National Laboratory
Location: Bethesda
Posted on: October 13, 2021

Job Description:

PROGRAM DESCRIPTION

The Frederick National Laboratory for Cancer Research (FNL) is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by the prime contractor Leidos Biomedical Research, Inc. FNL is responsible for pursuing a unique mission in translational and applied biomedical research that is unsuitable for academia, the pharmaceutical industry, or other federal contractors.This position will join the PK/PD specimen collection group located on the NIH campus in Bethesda, MD.

The PK/PD specimen collection group supports the NCI Developmental Therapeutics Clinic by providing specimen collection and processing support for investigational trials at the NIH Clinical Center.Work activities will be conducted in full compliance with written Standard Operating Procedures, laboratory certification/accreditation requirements, good clinical practice guidelines, and other elements of a Quality Assurance Plan. Work involves potentially hazardous chemical and biological materials and requires use of personal protective equipment and strict adherence to safety protocols.

KEY ROLES/RESPONSIBILITIES

• Independently supervise, operate, and ensure optimal specimen handling quality in a clinical research specimen service that supports early-phase clinical trials on the NIH campus in Bethesda
• Manage the handling (i.e., pickup, label, transport, process, distribute, track, etc.) of biological research specimens, including blood and human tissue, per protocol instructions in a clinical research environment
• Serve as a liaison with clinicians and nurses at the NIH clinical center to ensure program needs are being met
• Maintain detailed records of all clinical samples in compliance with good clinical practice guidelines and Clinical Center requirements
• Develop and ensure staff compliance with SOPs and other QA elements
• Communicate with various clinical and laboratory units at the NIH campus, the Frederick campus, and various collaborative sites to coordinate specimen collections with clinical activities and provide timely updates of the status of time sensitive specimens
• Perform laboratory procedures that include plasma separation, PBMC isolation, tissue preservation, cell counting, and cell enrichment
• Ship frozen and fresh samples to multiple clinical assay laboratories, as indicated by protocols
• Cover/arrange staff to cover occasional late night and weekend sampling, as needed, to maintain 24/7 sample coverage

• Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) with course work in a field related to biomedical researchor four (4) years relevant experience in lieu of degree. Foreign degrees will be evaluated for U.S. equivalency
• In addition to educational requirements, a minimum of eight (8) years of progressively responsible job related biomedical experience
• Laboratory experience in a clinical research setting including experience performing basic laboratory techniques with patient specimens: pipetting, centrifuge use, balance use, etc.
• Ability to work effectively in a team environment with both clinical and laboratory staff
• Ability to work in a highly organized fashion with accurate record keeping
• Experience with laboratory quality control/quality assurance processes
• Experience processing blood and/or other body fluids
• Experience using an electronic inventory system to track specimens
• Experience abiding by good clinical practice regulations
• Demonstrated proficiency working with Microsoft Office (Word, Excel, and Outlook) and strong general computer skills

• Experience with clinical trials and other protocol driven clinical research
• Participation in CLIA certification process
• Experience with handling and processing of tumor biopsy specimens
• Experience with specimen processing from multiple, simultaneous clinical trials
• Effective verbal and written communication skills

• This position is subject to working with or have potential for exposure to animal(s) and/or animal material(s)
• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
• This position is subject to working with or have the potential for exposure to laser emissions, requiring medical clearance
• This position is subject to the environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job

Keywords: Frederick National Laboratory, Bethesda , Supervisor, Clinical Trial Specimen Lab (req1985), Other , Bethesda, Maryland