Clinical Research Associate II in Bethesda, MD

Description

Clinical Research Associate II

Job ID: req1557
Employee Type: exempt full-time
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 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 Research Directorate (CRD), various clinical support teams provide 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), the National Institute of Mental Health (NIMH) and the National Institute of Environmental Health Sciences (NIEHS). CRD'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, CRD 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. CRD'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 Research Directorate (CRD) provides regulatory, clinical trials management, pharmacovigilance, protocol development/navigation and program management support to the NCI's Genitourinary Malignancies Branch (GMB).              

KEY ROLES/RESPONSIBILITIES

• Prepares and presents technical reports, abstracts, manuscripts, and other scientific presentations
• Secures electronic file transmissions of medical records, tests (ECG, MRI, CT, etc.) through various portals that are provided by trial sponsors
• Develops Standard Operating Procedures, templates and flow diagrams to enhance workflow
• Monitors/prepares budget operating reports
• Provides project management support with planning and development of project schedules and deliverables
• Develops and tracks project timelines and milestones
• Prepares status reports and monitoring progress ensuring adherence to deadlines
• Assist the research nurses with queries from research sponsors
• Maintains relationships with Investigators, study site staff, network entities, Clinical Research Organizations (CROs) and field CRAs
• Provides assistance to the clinical investigators and teams to reinforce and enhance a GCP culture
• Assists other CRAs and Project Managers in the development of team processes and study-related documents
• This position is located in Bethesda, 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 and/or health or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency 
• In addition to the education requirements, a minimum of two (2) years of related experience
• Ability to work in a clinical research setting, both independently and within a team
• Ability to prioritize multiple tasks/projects and accomplish goals in expected timelines through effective organizational and planning skills
• Ability to communicate effectively, verbally and in writing, with non-technical and technical staff
• Knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and ICH/GCPs
• Proficiency with Microsoft Office products including Microsoft Word, Outlook and Excel
• Experience with electronic or remote data capture monitoring as well as paper-based monitoring
• Previous clinical on-site monitoring or site management experience
• Foreign degrees must be evaluated for U.S. equivalency
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• One (1) year directly related to overseeing multiple concurrent trials/sites and on-site clinical monitoring or clinical sites management experience
• ACRP Certified CRA or SOCRA Certified Clinical Research Professional
• Infectious diseases experience
• Knowledge of Department of Health and Human Service (DHHS) regulations
• Experience conducting federally funded studies
• Experience developing Case Report Forms (CRFs), eCRFs, manual of operations and study monitoring plans
• Ability to read and/or speak French or Spanish
• Knowledge of international regulatory requirements

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

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