Research Associate II Job ID: req1643 Employee Type: exempt full-time Facility: NIH Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 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. Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest. Position Overview: 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. KEY ROLES/RESPONSIBILITIES * 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. BASIC QUALIFICATIONS * Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for US equivalency * In addition to educational requirements, a minimum of five (5) years of related biomedical work 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 * Ability to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: * 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 JOB HAZARDS * 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 the 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) #readytowork