Laboratory Services Project Manager I - REMOTE

Job ID: req3421
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 support to the Collaborative Clinical Research Branch (CCRB) in the Division of Clinical Research (DCR), NIAID, which plays an integral role in facilitating the efficient and effective performance of NIAID research programs in the United States and internationally.

KEY ROLES/RESPONSIBILITIES

• Provides operational coordination support to DCR designated high-profile clinical research laboratories in Indonesia, Mexico, West Africa, US, and other countries as assigned
  
• Manages the day-to-day operation of the CCRB-supported laboratories, including coordinating activities of diverse laboratory research projects and ensuring availability of equipment and supplies
  
• Works with laboratory staff to ensure that laboratory equipment is available as needed, properly calibrated and in working order.
  
• Develops lists of reagents and consumables for assays and protocols
  
• Participates in planning for future equipment needs
  
• Reviews and recommends new equipment, schedules demonstrations, and initiates procurement.
  
• Participates in the development of standard operating procedures for overall laboratory operations and study-specific operations
  
• Assists in standard operating procedure development and documentation for assay validation and verification
  
• Orients and trains professional staff and others on the methods and procedures used in the laboratory
  
• Coordinates and helps with management of biological shipments
  
• Assists with activities of biorepositories including freezer systems and inventory management
  
• 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
  
• Skill in calibrating and operating sophisticated laboratory instruments
  
• Ability to work effectively with others to ensure the successful and timely completion of the research goals of the organization
  
• Other duties as assigned
  
• This position is 100% remote with the option for in office

**THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL**

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/biology/microbiology 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 four (4) years of experience in laboratory research and two (2) years managerial experience
• Experience related to clinical laboratory operations (e.g., development of Standard Operating Procedures [SOPs], validation and verification of new assays, expertise in laboratory equipment)
• Familiarity with laboratory procedures such as human sample screening, flow cytometry, immunoassays, sequencing etc.).
• 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
• Comprehensive knowledge of laboratory procedures for clinical research laboratories
• Proficiency in Windows® and Microsoft® Office Suite including Word®, Excel®, PowerPoint®, and Outlook®
• Must be willing and able to travel 30% 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)
  
• Ability to work in a clinical laboratory setting both independently and within a team of technical specialists and project leaders
  
• Experience working in international laboratories
  
• Experience working in resource limited settings
  
• Ability to apply working knowledge of clinical research relative to timetables to assess overall project timeliness and risks

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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