Job ID: req873
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA
The Frederick National Laboratory is dedicated to improving human health through discovery and innovation in the biomedical sciences, focusing on cancer, AIDS, and emerging infectious diseases.
The Applied and Developmental Research Directorate (ADRD) provides clinical and biological monitoring, regulatory support, biospecimen processing and storage, clinical assay development and validation, and project management support to the National Institute of Allergy and Infectious Disease (NIAID) and National Cancer Institute (NCI) clinical and translational programs, including the Division of Cancer Treatment and Diagnosis (DCTD). DCTD facilitates paths of unique molecules, diagnostic tests, and therapeutic interventions to clinical applications, including distinct molecular signatures for cancer, development and validation of molecular diagnostic tests and drug target assays, and state-of-the-art imaging techniques.
Perform biological specimen handling services, in a clinical research environment, in support of early-phase clinical trials on the NIH campus in Bethesda.
Maintain detailed records of all clinical samples in compliance with good clinical practice guidelines and Clinical Center requirements.
Perform sample handling and processing in compliance with Standard Operating Procedures (SOPs) and other QA/QC elements.
Perform laboratory procedures that include plasma separation, PBMC isolation, tissue preservation, cell counting, and cell enrichment.
Ship frozen and fresh samples, as needed.
Cover occasional late night and weekend sampling, as needed, to maintain 24/7 sample coverage.
Assist in development of new procedures to increase laboratory efficiency and productivity
Work activities will be conducted in full compliance with written SOPs, 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.
Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a biomedical research field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
In addition to educational requirements, a minimum of five (5) years 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
Must be able to obtain and maintain a security clearance
Experience with clinical trials and other protocol driven clinical research
Participation in CLIA certification process
Experience with specimen processing from multiple, simultaneous clinical trials
Effective verbal and written communication skills
Candidate will be working with or have the potential for exposure to animal(s) and/or animal material(s)
Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements.
Candidate would be working in or have the potential for exposure to high noise levels for extended period of time. This may require a medical clearance and enrollment into the Hearing Conservation Program.
Candidate is subject to the following environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job.
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)