Clinical Research Monitor II

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.

KEY ROLES/RESPONSIBILITIES

• Assess the completeness of regulatory files (including IRB approval documents, informed consent forms, manuscripts and other FDA required documentation).
• Examine clinical trial records to ensure appropriate regulatory record keeping, adherence to protocol and informed consent procedures, standard operating procedures and appropriate adverse event reporting.
• Perform periodic safety reviews for individual subjects, including reviewing case report forms, comparing to source documentation for completeness and accuracy.
• Maintain responsibility for clinical protocol review and approval; assurance of scientific quality and human subject's protection; the quality of care delivered to patients; and the quality of professional performance of the health care providers.
• Provide consultation and assistance to complete protocol lifecycle requirements (including continuing review applications, protocol amendments and applicable DSMB reviews).
• Provide quality assurance and quality control oversight of clinical trials, including GCP monitoring of non-IND protocols; IND and IDE clinical trial monitoring; general quality assurance for data acquisition; and development and maintenance of a database to track and tabulate adverse events and unanticipated adverse events.
• Assist with investigator site management activities in adherence to all applicable guidelines, including GCPs and other standard operating procedures per United States and international regulation.
• Assess various components of the clinical operation and management of sites, including the site's internal quality assurance and quality control methods and procedures.
• Coordinate, conduct and maintain responsiblity for clinical site management, including site initiation, routine monitoring and close-out visits.
• Provide training for new Clinical Research Associates, clinical investigators and administrative staff with regards to standard operating procedures, GCP and daily activities.
• Assist research staff in navigating requirements for special circumstances and facilitates access to services.
• Coordinate with investigators and medical writers to ensure stipulations are addressed appropriately and in a timely manner.
• Interact with internal and external personnel to facilitate project timelines.
• Oversee activities, such as Investigator meetings, study initiation, ongoing monitoring, and close-out visits.
• Perform data collections and analysis to support formal presentations for advisory councils and professional meetings.
• Develop special analytical reports that synthesize data and draw inferences and conclusions regarding program activities and/or policies.
• Manage and coordinate the tracking, receipt and analysis of the data and provide comprehensive statistical analysis and reports.
• Facilitate early discussions among investigators, data management teams, Clinical Research Associates, investigators, monitoring teams and statisticians to ensure processes are mutually understood and monitoring plans are acceptable to all.
• Provide support for clinical report writing and represent program on data-tracking committees.
• Work with investigators to establish a clinical monitoring plan.
• This position is located in Bethesda, 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 related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the educational requirements, a minimum of two (2) years of prior relevant experience
• 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
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• 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

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