Clinical Research Associate II Job ID: req1555 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 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 comprehensive, dedicated clinical research and study coordination in support of the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB). KEY ROLES/RESPONSIBILITIES Assists with scientific publications and presentations and prepare scientific peer-reviewed manuscripts for journal publication Participates in scientific review of manuscripts for scholarly journals, textbooks, or edited book chapters, and/or abstracts for papers and posters submitted for presentation at conferences Participates in review groups for the review of study proposals or protocols Identifies and resolve potential problems Interacts and collaborates with other scientific staff, practitioners and public health administrators Provides consultative input and expertise in research and evaluation Works with supervisor in the development of new assignments, program goals, and objective Specifics: Biospecimens for 1) Pediatric and Adult Clinics, 2) Field Cohort and 3) Specialty Clinics: Work with Research Nurse to determine protocol requirements Collection, handling and processing Tracking Communication with patients and outside institutions Shipping coordination Pathology: Request path and path reports from outside institutions as required per protocol Storing Submitting to NIH Pathology Shipping Imaging: Request scans from outside institutions as required per protocol Uploading to Imaging Radiology Library Tracking Return scans to patients Protocols: Protect the integrity of the protocols by adhereing to protocol requirements Complete forms as needed Participate in team meetings Administrative/Regulatory: Maintain spreadsheets of data collected Maintain and/or verify database with sample data Maintain accurate and complete documentation according to protocol, sponsor and institutional requirements May travel to assist field sites This position is located in Bethesda, Maryland 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/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 related experience in lieu of degree Foreign degrees must be evaluated for US equivalency A minimum of five (5) years of progressively responsible experience in biomedical research including a minimum of one (1) year directly related to overseeing multiple concurrent clinical trials 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 Ability to communicate effectively, verbally and in writing, as well as give presentations with non-technical and technical staff General knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and GCPs Knowledge of TrackWise , or other Clinical Trials Management Systems (similar systems such as OpenClinica, ClinPlus, RedCap etc.) Extensive experience using various software applications such as MS Excel, Word, PowerPoint, and Adobe Acrobat; relational database structures and reporting software Ability to manage projects involving large volumes of data Must be willing to travel Previous clinical monitoring or site management experience Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Oncology experience Knowledge of Department of Health and Human Service (DHHS) regulations is a plus Experience with the development of manual of operations and study monitoring plans Knowledge of conducting federally funded studies ACRP Certified CRA or SOCRA Certified Clinical Research Professional Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW) #readytowork