Research Scientist III

Job ID: req4684 Employee Type: exempt full-time Division: Clinical Monitoring Research Program Facility: Telework: US Location: USA The Frederick National Laboratory is 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 Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD’s ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD’s support services are aligned with the program’s mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program Directorate (CMRPD) provides comprehensive clinical support to the NIAID Division of Microbiology and Infectious Diseases (DMID) supporting clinical research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics. This position will support operations in NIAID-supported research initiatives in the US, West and Central, Africa, Indonesia, and Mexico for the Collaborative Clinical Research Branch (CCRB) within the DMID. Position may travel up to 25% domestically and internationally. Key Roles/Responsibilities Serves as subject matter expert on all aspects of clinical research endpoint assays, including sample collection, processing, shipping, and testingActs as primary point of contact for laboratory oversight, including PBMC processing, immune monitoring, and specimen handling across designated high-profile clinical research laboratories in the US, Indonesia, Mexico, West and Central Africa, and other countries as assignedManages day-to-day laboratory operations, including coordinating a portfolio of diverse laboratory research projects and ensuring availability of equipment, reagents, and suppliesAssists in assay determination, development, qualification, and validation for clinical laboratory operationsReviews and advises on assay development qualification reports prior to sample shipmentDevelops reagent/consumable lists for maintaining general laboratory operations and study specific needsEstablishes and maintains a Central Assay Plan (CAP)Drafts and develops the Manual of Procedures (MOP) for laboratory operationsCreates and tracks timelines for sample collection through lab assay report generationDefines and coordinates specimen collection and assay needs, including supplies and trainingAssists in generating research sample picklists and coordinates with specimen repositories for shipment and receiptReviews lab deviations and troubleshoots issues related to aliquots, temperature excursions, and site-level problemsTrains professional staff and facilitates information sessions on laboratory methodology (e.g., biosafety, biosecurity, good laboratory practices) and procedures; identifies laboratory training needs and prepares materials for sites/labsEnsures laboratory equipment is properly calibrated and operational; reviews and recommends new equipment and participates in procurement planningParticipates in the development of standard operating procedures for overall laboratory operations and study-specific operationsSupports development and implementation of various technical and logistical tracking systems to meet research and operational needsAssists with activities of biorepositories, including implementation of freezer and inventory management processesApplies risk management strategies and quality control practices to ensure continuity of laboratory servicesAbility to collaborate with scientists and provide guidance on the management of the laboratoryAbility to interpret, ensure quality assurance, and report laboratory dataAbility to write clearly, including in summary result reporting and in the development of scientific manuscriptsAbility to work effectively with others to ensure the successful and timely completion of the research goals of the organizationThis position will be remote and on occasion need to be onsite at the Integrated Research Facility (IRF-Frederick) at Fort Detrick, Frederick, MDMust obtain and maintain public trust security clearance and may need to obtain a security clearance with a TIER III designation as requiredUpon TIER III designation, this position will require enrollment in the NIAID Biosurety Program and the CDC Select Agent Program Basic Qualifications To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of a PhD from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/biology/microbiology. Foreign degrees must be evaluated for U.S. equivalencyIn addition to the education requirement, a minimum of five (5) years of progressively responsible experience in laboratory researchComprehensive knowledge of Good Laboratory Practices (GLP) and laboratory procedures for clinical research laboratoriesExperience operating in the BSL-4 settingDemonstrated experience in clinical laboratory operations, including SOP development, assay validation and verification, and expertise in laboratory equipmentExperience working and collaborating with scientific teams, and staff-training in international laboratories, including in resource-limited settingsExperience serving as a subject matter expert and primary point of contact for laboratory oversight functionsExperience in assay determination, development, qualification, and validation for clinical laboratory operationsProficiency in interpretation, quality control and assurance, and reporting of laboratory dataProficiency in scientific writing, including in summary result reporting and in the development of scientific manuscriptsMust be detail oriented. Possesses strong verbal communication, writing and organizational skills, including the ability to prioritize multiple tasks and projectsAbility to work well under pressure, apply technical expertise, and make sound decisionsFlexibility and willingness to adapt in a changing environmentAbility to take initiative and make an active contribution to the team's performanceProficiency in Windows® and Microsoft® Office Suite including Word®, Excel®, PowerPoint®, and Outlook®Must be willing and able to travel up to 25% domestically and internationallyAbility to obtain and maintain a security clearance Preferred Qualifications Candidates with these desired skills will be given preferential consideration: Familiarity with Good Clinical Practices (GCP)Ability to work independently and as a team member in a clinical research laboratory setting and within a team of technical specialists and project leadersAbility to apply working knowledge of clinical research relative to timetables to assess overall project timeliness and risksExperience working in international laboratoriesExperience working in resource limited settingsExperience establishing Central Assay Plans (CAP) and Manuals of Procedure (MOP)Experience training and mentoring junior laboratory staff Commitment to Non-Discrimination All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, 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. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws. Pay And Benefits Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here 113,500.00 - 162,533.00 USD The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data. The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions