Leidos Clinical Research Associate I (NCI) in BETHESDA, Maryland

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



*JOB DESCRIPTION/BASIC FUNCTION: *

The Clinical Monitoring Research Program (CMRP) provides comprehensive, dedicated clinical research and study coordination support to the National Institute of Allergy and Infectious Diseases (NIAID) Division of Clinical Research (DCR), Intramural Clinical Management and Operations Branch (ICMOB). It also supports the NIAID’s research collaboration with the Children's National Medical Center (CNMC).

Responsibilities:

  • Designs, plans and implements the overall direction of clinical research projects

  • Evaluates and analyzes clinical data

  • Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives

  • Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings

  • May draft materials including informed consent documents, draft source documents, patient instruction guides and case report forms (CRFs)

  • Conducts clinical monitoring of field sites to supervise and coordinate clinical studies

  • May write protocols

  • May require travel to field sites

  • Assists with the recruitment of research participants and the collection, management, and analysis of specimens and data

  • Assists with protocol development and contributes to the preparation of regulatory submissions to the Institutional Review Board (IRB)

  • Monitors intramural research protocols and ensures the clinical trials are conducted in accordance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and all applicable regulatory guidelines

  • Assists with opening, monitoring, and closing studies, clinical site management, and managing the relationship with Clinical Research Organizations (CROs) and field CRAs

  • Ensures appropriate reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  • Reviews clinical trial data for quality and completeness

  • Tracks patient enrollment, randomization, and drug dispensing

  • Ensures the safety and confidentiality of study subjects

  • Interacts with internal and external staff to facilitate project timelines

  • Assists in preparing documents to be submitted to the Food and Drug Administration (FDA), as well as annual protocol reports, manuscripts, and abstracts for publication

  • Attends laboratory and clinic meetings, clinic conferences, and other seminars/meetings

  • Travels occasionally for domestic and international conferences

  • Acts as the liaison to NIH and CNMC staff to ensure clinical trials are well coordinated

  • Coordinates and guides patients through study visits and is the Point of Contact (POC) for patients associated with the different studies

  • Works in collaboration with the Study Coordinators and Case Managers associated with the studies

Work will be conducted at the NIH Bethesda Campus and at CNMC and/or clinics located in the DC Metro area

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 or university according to the Council Higher Education Accreditation (CHEA) in a field related to biomedical research, clinical trials and/or health, or four (4) years related experience in lieu of degree

  • Foreign degrees must be evaluated for U.S. equivalency

  • No experience required with a Bachelor’s degree

  • Must be able to obtain and maintain a Public Trust Clearance

Additional Required Skills/Experience:

  • Biomedical research or clinical related experience may be substituted for the degree

  • Must have knowledge in reference to good clinical practices regulations and standard operating procedures.

  • Ability to work in a clinical research setting both independently and within a team environment

  • Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

  • Ability to communicate effectively, orally and in writing, with non-technical and technical staff

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

  • Familiarity with FDA regulatory requirements and guidelines for clinical research, as well as monitoring requirements

  • Infectious disease experience

  • Knowledge of Department of Health and Human Services regulations

  • Experience with the development of CRFs, FrameMaker® and TrackWise®

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 is an Equal Opportunity Employer.