Research Scientist I Clinical Laboratory Operations (NIAID)

Research Scientist I Clinical Laboratory Operations (NIAID)

Job ID: req4323
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. CMRPDs 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. CMRPDs support services are aligned with the programs 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. CMRPDs collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPDs 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 is 100% remote. Candidates must reside in the U.S.

KEY ROLES/RESPONSIBILITIES

• Provides laboratory subject matter expertise and day-to-day operational and administrative support to facilitate clinical trial protocol endpoint assay testing, including oversight of sample collection, sample processing, shipping, coordination of picklists, review of assay qualification/validation reports, specimen testing and data uploads.
• Participates in the development of standard operating procedures for overall laboratory operations and study-specific operations.
• Contributes to drafting and developing the Manual of Procedures (MOP) for specimen collection and processing at the clinical sites.
• Prepares training materials, and contributes to training site labs remotely for specimen collection and processing.
• Reviews lab deviations from data system and identifies issues that may require follow-up (at site and/or study level) such as monitoring number of aliquots collected, temperature excursions, etc.,
• Supports the research team by locating and reviewing the literature pertinent to the project to identify the most applicable methods and supplies.
• Identifies, tracks, troubleshoots and resolves issues at site labs.
• Coordinates home nasal swab collections, including supporting the implementation of an application to remind participants to collect samples at home and for tracking samples from collection through shipping and receipt at endpoint testing lab.
• Contributes to establishing and maintaining a Central Assay Plan (CAP).
• Participates in the review of potential endpoint lab vendor statements of work (SOWs) and proposals to support endpoint testing.
• Assists with tracking and reviewing standard operating procedure development, and assay qualification/validation/ verification reports and documentation, and ensures assay is at the appropriate level for endpoint testing.
• Facilitates endpoint assay testing including requesting the data management coordinating center for picklists and coordinating specimen shipments.
• Tracks and updates timelines for sample testing including sample collection and processing at site, shipping from site to repository, shipping from repository to endpoint lab, lab testing timelines, date upload from lab to data management coordinating center, and resulting report dissemination.
• Identifies, tracks, and resolves issues at endpoint assay labs.
• Identifies reagents and consumables for specimen collection and processing at sites.
• Ensures availability of supplies at study repository for site ordering, including initiating supply procurement requests, maintaining and reviewing inventory, and identifying and working through supply issues.
• Identifies required equipment and works with site laboratory staff to ensure that laboratory equipment is available as needed, properly calibrated, and in working order.
• Creates timelines and tracks activities to support DMID reporting needs.
• 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.
• This position is 100% telework (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 degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Foreign degrees must be evaluated for U.S. equivalency.
• No work experience required with a Doctorate.
• 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.
• 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).
• Experience conducting specimen collection, processing, or testing of clinical specimens.
• Clinical research with infectious disease experience, preferably SARS-CoV-2.
• Familiarity with assays used to assess the immune responses.
• Experience with collection and processing PBMCs.
• Familiarity with supply management and inventory.
• Experience related to clinical laboratory operations (e.g., development of Standard Operating Procedures [SOPs], validation and verification of new assays, expertise in laboratory equipment).
• Comprehensive knowledge of laboratory procedures for clinical research laboratories.
• Experience conducting federally funded research studies under subcontracting mechanisms.

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

91,300.00 - 156,875.00

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