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Clinical Trials Manager I

Job ID: req1377
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, COVID19, 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 regulatory, clinical trials management, pharmacovigilance, protocol development/navigation and program management support to the Regulatory Compliance and Human Subjects Protection Program (RCHSPP), Office of Clinical Research Policy and Regulatory Operations (OCRPRO) of the National Institute of Allergy and Infectious Diseases’ (NIAID) Division of Clinical Research (DCR).

KEY ROLES/RESPONSIBILITIES

  • Performs project and Clinical Trials Management (CTM) resource planning, research, contract review, analysis, correspondence control, communication and liaison activities, which may include coordinating activities with multiple groups for Network studies located domestically and internationally
  • Assists with identifying appropriate resources and organizing project teams to ensure communication and understanding of deadlines, assignments and objectives
  • Provides mentoring and leadership to the CTM team members
  • Provides assistance to investigators and the Institutional Review Board (IRB) in the development of protocol specific GCP monitoring plans
  • Drafts/reviews documents such as team presentations for SIVs, and trainings, consent form templates and study manuals/review for CRA, Attend SIV as CPM on behalf of NIAID/NIAMS studies
  • Reviews and approves site visit reports and letters from CRAs prior to and upon completion
  • Implements periodic administrative review of SOPs, for process and regulatory changes as necessary
  • Provides support as needed for clinical report writing and annual FDA reports
  • Provides training for new CRA's on SOPs, new NIH polices and daily activities
  • Manages and coordinates activities to CRAs associated with the conduct of clinical trials
  • Assists with scheduling MVs for CRAs with NIH medical legal
  • Assists with the design, planning and implementation of clinical trials
  • Assists with writing, editing and training staff on Clinical Trials Monitoring SOPs
  • Assists in managing and coordinating project activities associated with monitoring functions
  • Strategizes on study start up activities and oversees day to day operations of assigned projects
  • Serves as liaison to outside vendors on contracts and vendor activities; reports contract inconsistencies for CRO work
  • Establishes study Monitoring Plan matrices, templates, and monitoring plans for protocols with lead CRAs
  • Mentors and provides leadership to CTM team members regarding clinical trial regulations, training of CTM SOPs and site processes
  • Assists with the updates and maintains quality control over the NIAMS CMRPD templates such as reports and NIAMS monitoring guidelines
  • Serves as Subject Matter Expert on various aspects of clinical trials such as; human subjects protections
  • Supervises CTM employees
  • This position is located in Frederick, Maryland

BASIC QUALIFICATIONS

  • 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/clinical trials/health (Additional qualifying experience may be substituted for the required education)
  • Foreign degrees must be evaluated for U.S. equivalency
  • A minimum of six (6) years of progressively responsible relevant experience in clinical research including a minimum of three (3) years directly managing multiple concurrent clinical trials
  • Extensive knowledge of clinical and outcomes research study design
  • Ability to work effectively on cross-functional teams and
  • Experience working with CROs and monitoring requirements
  • Experience related to clinical operations (e.g., development of SOPs, staff development and training, resourcing/staffing and budget planning and execution)
  • Must be detail-oriented and possess strong organizational skills with ability to prioritize multiple tasks/projects
  • Ability to work in a clinical research setting both independently and within a team
  • Ability to travel approximately 20%
  • Knowledge of clinical trial fieldwork concepts and practices
  • Must be well versed in FDA regulations and GCPs as well as other regulatory requirements and international guidelines for clinical research, with specific knowledge of monitoring requirements
  • Ability to create and maintain tracking databases
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

  • Ability to multi-task and tackle difficult study related issues
  • Bilingual (Spanish)
  • Familiarity with regulatory requirements and guidelines for facilitating clinical human subjects research, as well as monitoring requirements to ensure integrity of data and site compliance
  • A minimum of one (1) year supervisory experience
  • Experience with contracts and domestic/international trials
  • Detailed oriented individual who exercises good judgment in planning, accomplishing goals and meeting timelines.
  • Experience with monitoring studies in Mexico, Africa, Asia and other countries
  • Working NIAID experience
  • Knowledge of 508 Compliance, Ministry of Health, International agencies, and Department of Health and Human Services regulations
  • Experience with the development of CRFs, eCRFs, manual of operations, study monitoring plans and risk-based monitoring strategies
  • Knowledge of conducting federally funded studies
  • Certified clinical research professional
  • Strong writing and proof-reading skills
  • Maintaining a collaborative working relationship with the site Principal Investigators, study staff and CROs/outside monitors

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

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