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IRB Administrator (NCI)

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Job Number:
643907
Job Category:
Healthcare / Life Sciences / Medical
Location:
ROCKVILLE, MD US
Schedule:
Full-time
Travel:
None
Shift:
Day Job
Potential for Teleworking:
No
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
Public Trust
Description:

PROGRAM DESCRIPTION

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program (CMRP) provides management, administration, and coordination of IRB operations and activities for the Office of Regulatory Affairs, Office of the Director.

KEY ROLES/RESPONSIBILITIES

  • Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local SOPs and federal regulations
  • Supports the IRB (Institutional Review Board) infrastructure by assisting in the management, administration, and coordination of IRB operations and activities and by serving as an authoritative resource to clinical branches for information and guidance on regulatory, policy, and procedural requirements
  • Preparation and submittal of complex clinical protocols and related actions (e.g., continuing reviews, amendments, etc.) for review
  • Reviews protocol actions (new requests, responses to stipulations, amendments, continuing reviews, closures, etc.) prior to submission to the IRB for compliance with regulatory, policy, and procedural requirements and for completeness, appropriateness, and adequacy of information (e.g., ensuring sufficient detail for review, ensuring required elements have been addressed)
  • Applies knowledge of regulations and policies related to Federal, NIH, and NCI human subjects protection program to identify components of protocol requests that need additional information or correction
  • Works closely with Principal Investigators and other appropriate staff to advise them of complex regulatory, ethical, and procedural requirements that must be met before final approval of the protocol is granted
  • Monitors and improves tracking/control systems and keeps abreast of regulatory procedures and changes
  • Assists in the administration and coordination of IRB meetings by performing such duties as scheduling presentations by Principal Investigators who have actions submitted for review; monitoring maintenance of quorum; monitoring and advising on which members cannot be present based on conflicts of interest; reviewing meeting minutes for technical accuracy; and following-up on recommendations, decisions, and action items as requested

This position is located in Rockville, Maryland


Qualifications:

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 related discipline (Additional qualifying experience may be substituted for the required education)
  • Foreign degrees must be evaluated for U.S. equivalency
  • A minimum of two (2) years related experience in clinical protocols or human subjects protection
  • Ability to review sections of clinical trial protocols to ensure appropriate guidelines are followed for human subjects protection
  • Ability to communicate effectively, orally and in writing, with technical and non-technical individuals both internally and externally
  • Ability to work independently and utilize effective problem-solving techniques to handle allegations, complaints and non-compliance issues
  • Ability to prioritize and multi-task in order to meet the needs of the IRB office
  • Ability to work effectively as part of multi-organizational and multi-disciplinary team
  • Ability to interpret and effectively communicate federal regulations
  • Knowledge of clinical trial databases and computer software applications, including Microsoft Office® (i.e., Access, Word and Excel)
  • In-depth knowledge of department specific regulatory requirements (i.e., Department of Health and Human Services [DHHS], National Institutes of Health [NIH], the U.S. Food and Drug Administration [FDA], IRB, and Good Clinical Practices [GCP])
  • General knowledge of biological principles, scientific methods and medical terminology
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration

  • Clinical research, medical laboratory, nursing and/or allied health experience
  • Knowledge of IRB processes


Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.
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