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Clinical Trials Manager II - Bilingual

Job ID: req1623
Employee Type: exempt full-time
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 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.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 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 specialized support services for initiatives in support of the National Cancer Institute (NCI).  CMRPD is responsible for establishing and maintaining clinical trials regulatory and auditing support services for the NCI DCP US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet).  This position may support various institutes of the NIH.  

KEY ROLES/RESPONSIBILITIES

Responsibilities include but are not limited to:

  • Assists with the planning and implementation of clinical trials
  • Undertake and participate in auditing visits and facilitate follow up resolutions
  • May undertake and participate in other visits (e.g. site initiation, site closeout)
  • Review clinical trials documents and verification of data (via source data review) for study documents including (but not limited to) study protocol, Informed Consent Forms, patient information material, recruitment and retention information guides, and Case Report Forms
  • Monitor progress of clinical studies by analyzing progress reports such as monthly minimum dataset submissions (MDS), patient accrual reports, and other clinical trials monitoring activities performed by the Partnership Center
  • Ensure quality of data generated from clinical sites and assist in resolving patient eligibility and protocol deviation issues
  • Serve as a liaison and resource for assigned clinical accrual sites as well as, serves as a liaison between various Leidos Biomed, NCI entities and collaborating offices, interacting with both scientific and administrative officials
  • Analyze audit findings, identify and report trends, and make improvement recommendations to management
  • Coordinates and communicates efforts within the assigned activities to include organizing, planning, executing, reporting and evaluating the assigned program objectives
  • Identifies and assesses clinical trial sites and the necessary infrastructure to carry out clinical studies domestically and internationally, including clinical site assessment, clinical site preparation, clinical site training and clinical site logistical support
  • May assist in assessment of site preparedness and perform site qualification visits
  • Provides mentoring, leadership and may supervise other staff
  • Travels up to 30%
  • This position is located in Frederick, Maryland

BASIC QUALIFICATIONS

  • Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency.   
  • In addition to educational requirements, a minimum of eight (8) years of progressively responsible relevant experience in clinical research including a minimum of three (3) years directly managing multiple concurrent clinical trials
  • Fluency in Spanish and/or Portuguese is required
  • Clinical trial project management experience including experience as a Clinical Research Associate of Specialist
  • Direct experience in auditing/monitoring clinical trials in diverse patient settings
  • International clinical trials experience
  • Progressively increasing clinical site monitoring/auditing experience, management of multiple concurrent clinical trials/projects and supervisory experience
  • Experience in preparing and managing site management plans
  • Proficiency in all functions of clinical research implementation processes and conduct
  • In-depth knowledge of the clinical trial and drug development process
  • Ability to work in a clinical research setting both independently and within a team to coordinate, negotiate, and facilitate data
  • Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCP), ICH, and relevant regulatory agency requirements domestically and internationally.
  • Knowledge of clinical trial fieldwork concepts and practices
  • Ability to travel domestic and internationally
  • Strong skills in MS Word, Excel, and Outlook.
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Infectious disease clinical research experience
  • Knowledge of Quality Assurance/Quality Control processes
  • Knowledge of site selection activities and tracking site capabilities
  • Organized, detail oriented, and have excellent written and oral communication skills
  • Works independently functioning within a multidisciplinary team environment
  • Excellent skills in prioritization, problem solving, organization, decision-making, time management and planning
  • Ability to prioritize effort across multiple projects and subject areas
  • Experience working on NIH funded studies
  • SoCRA or ACRP certification

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

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