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Clinical Training Specialist

Job ID: req1095
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 USA

The Frederick National Laboratory is dedicated to improving human health through discovery and innovation in the biomedical sciences, focusing on cancer, AIDS, and emerging infectious diseases. 

Position Overview:

PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) 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 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, CMRPD’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. CMRPD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) 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, CMRPD services include comprehensive clinical trials monitoring, 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. CMRPD’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 Directorate (CMRPD) provides comprehensive programmatic/project and procurement management support to the Office of Planning and Operations Support (OPOS) and Regulatory Compliance and Human Subjects Protection Branch/Program (RCHSPB/P) within the National Institute of Allergy and Infectious Diseases’ (NIAID) Division of Clinical Research (DCR).   

KEY ROLES/RESPONSIBILITIES

  • Develops, coordinates, and implements the CMRP and the OPOS training programs
  • Designs and implements interactive, competency-based computer-based training programs
  • Develops target-audience appropriate quality assurance components for all training programs
  • Develops training process flows, training needs analysis, competency-based training, session implementation, configuration and implementation of training event documentation
  • Maintains audit-ready training record status (electronic and hard copy)
  • Performs training program evaluations and training material maintenance
  • Works with area supervisory staff in compliance with training procedures and policies
  • Provides instructor-led training programs
  • Facilitates electronic training events as required
  • Contributes to new employee orientation program for CMRP operations
  • Authors sections of reports as required
  • Maintains L&PD project tracking tools
  • Travels approximately 10% annually both domestically and internationally supporting training events
  • This position is located in Frederick, Maryland 

BASIC QUALIFICATIONS

  • Possession of a bachelor’s degree in secondary education/adult learning, nursing, biological sciences or a related field from an accredited college or university according to the Council for Higher Education Accreditation, or four (4) years related experience in lieu of a degree.  Foreign degrees must be evaluated for U.S. equivalency
  • A minimum of four (4) years of training/education experience in an academic or workplace environment, preferably in an industrial/clinical environment
  • Extensive experience creating, implementing, evaluating, and maintaining interactive learning technology and distributive learning technology
  • Excellent instructional design/presentation skills and extensive adult learning strategy experience
  • Familiarity with competency-based training
  • Experience with training record management (hard copy and electronic)
  • Demonstrated skill in performing a training needs assessment and development of competency-based training to address specific training needs
  • Experience with identification, application and interpretation of training effectiveness metrics
  • Experience providing technical as well as professional skills training
  • Experience with multi-generations learning audiences
  • Ability to interact with all levels of management
  • Ability to complete tasks with minimal information/instruction
  • Ability to adjust to changing customer requirements and deal with changing priorities (flexibility)
  • Strong writing and creative problem-solving skills
  • Ability to work in an office environment both independently and as a team member to build strong collaborative skills and relationships within multiple groups
  • Demonstrated ability to exercise sound judgment in planning, prioritizing, organizing and accomplishing goals and multiple tasks or projects
  • Strong customer service orientation
  • Ability to travel up to 10% domestically and internationally
  • Proficient with MS Office Software
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

  • Master’s degree in education/adult learning focus preferred
  • Knowledge of testing in the workplace
  • Experience with Visio and project management
  • General knowledge of GCPs as they apply to clinical research

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