Research Scientist II - Lab Expert - Remote

Research Scientist II - Lab Expert - Remote

Job ID: req3740
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
Location: 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
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. 

KEY ROLES/RESPONSIBILITIES

• Laboratory subject matter expertise and operational/administrative support for tracking samples per study to multiple labs based on central assay plans, coordination of picklists, tracking of data uploads and serving as Point of Contact for Laboratory Operations
• Serves as a participating member of a research team and is responsible for locating and reviewing the literature pertinent to the project to identify the most applicable protocols and methods
• Manages the day-to-day operation of the supported laboratories, including coordinating activities of diverse laboratory research projects and ensuring availability of equipment and supplies
• Organizes and coordinates: Home nasal swab collections, including implementation of an application to remind participants to collect samples at home and for tracking purposes – samples from collection through shipping and receipt at testing lab
• Provides subject matter expertise on all aspects of clinical research supporting endpoint assays, including sample collection, processing, shipping, review of assay qualification and validation reports, specimen testing
• Reviews and advises on assay development qualification reports, ensuring assay is at the appropriate level prior to shipment of samples to designated laboratories
• Establishes and maintains a Central Assay Plan (CAP)
• Drafts and assists in development of the Manual of Procedures (MOP) for laboratory operations including the collection and processing of specimens at site
• Defines and coordinates specimen collection and assay needs (supplies, training, etc.)
• Identifies site training needs, prepares materials, and trains sites/labs for specimen collection and processing
• Creates timelines and track activities to support DMID reporting needs
• Creates, tracks/updates timelines for sample collection through to generation of lab assay reports including from site to sample repository, from sample repository to lab, lab processing, and upload from lab to data management coordinating center
• Assists in generation of picklists via the data management coordinating center. Coordination with the specimen repository for shipment and receipt of samples
• Reviews Lab Deviations from data system and identifies issues that may require follow-up (at site and/or study level) to include, but not limited to, monitoring number of aliquots collected, temperature excursions, etc., troubleshooting of issues encountered with the sites
• Works through issues about supplies, testing, etc.
• Identifies, tracks, resolves issues at processing labs (site)
• Identifies, tracks, and resolves issues at endpoint assay labs
• Serves as point of contact for laboratory oversight which includes, but is not limited to, PBMC processing, storage, and shipment, immune monitoring, questions related to endpoint lab assays, and specimen processing, storage, and shipment of specimens
• Works with laboratory staff to ensure that laboratory equipment is available as needed, properly calibrated, and in working order
• Reviews and recommends new equipment, schedules demonstrations, and initiates procurement. Participates in planning for future equipment needs
• Participates in the development of standard operating procedures for overall laboratory operations and study-specific operations
• Assists in assay determination for clinical laboratory operations and associated research studies.
• Develops lists of reagents and consumables for assays and protocols
• Assists in standard operating procedure development and documentation for assay validation and verification
• Provides support to the development and implementation of various technical and logistical tracking systems to meet research and operational needs across the high-profile clinical research projects
• Ability to work effectively with others to ensure the successful and timely completion of the research goals of the organization
• May supervise staff
• This position is 100% Telework and will work East Coast hours

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. equivalency
• In addition to educational requirements, a minimum of two (2) years of experience in laboratory research
• Experience related to clinical laboratory operations (e.g., development of Standard Operating Procedures [SOPs], validation and verification of new assays, expertise in laboratory equipment)
• Must be detail oriented. Possesses strong verbal communication, writing and organizational skills, including the ability to prioritize multiple tasks and projects
• Ability to work well under pressure, apply technical expertise, and make sound decisions
• Flexibility and willingness to adapt in a changing environment
• Ability to work independently and as a team member with consistent ability to take initiative and make an active contribution to the team's performance.
• Ability to make administrative and procedural decisions.
• Comprehensive knowledge of laboratory procedures for clinical research laboratories
• Proficiency in Windows® and Microsoft® Office Suite including Word®, Excel®, PowerPoint®, and Outlook®
• Ability to travel up to 10% domestically and internationally.
• Ability to obtain and maintain a security clearance 

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Familiarity with Good Laboratory Practices (GLP)
• Familiarity with management of study products and supplies
• Experience conducting federally funded research studies under subcontracting mechanisms
• Clinical research with infectious disease experience, preferably SARS-CoV-2
• Experience with reviewing data for safety signals
• Ability to apply working knowledge of clinical research relative to timetables to assess overall project timeliness and risks

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, 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. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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