Protocol Nurse Coordinator (NCI)

Leidos Biomedical Research, Inc.
Bethesda, MD
Jun 12, 2018
Jun 22, 2018
Full Time
Description: PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.'s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) Directorate 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 Institute of 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, CMRP'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. CMRP's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health 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, CMRP services include comprehensive clinical trials, 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. CMRP'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 supports the mission of the Cardiovascular Intervention Program within the Cardiovascular Branch of the NHLBI Division of Intramural Research for development of new catheter-based treatments for cardiovascular disease in adults and children for testing in a pre-clinical setting and at collaborating medical centers. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Protocol Nurse Coordinator III: - Coordinates and manages a portfolio of clinical trials, providing support to streamline processes needed for optimum protocol implementation across various sites - Facilitates early discussions among investigators, research teams and statisticians to ensure processes are mutually understood and acceptable to all - Orchestrates meetings with investigators and other key medical staff to identify required support to carry out well-controlled clinical trials - Works directly with investigators and study team members on the production and revision of clinical research protocols and Informed Consent Forms (ICFs) and facilitates the activities of writing and regulatory review with bi-directional dialogue and feedback - Coordinates with site investigators and coordinators regarding enrollment, adverse event (AE) assessment and documentation and evaluation of CRFs - Oversees site coordinator data entry in approved clinical databases - Obtains informed consent and determines study eligibility for subjects to be enrolled in NIH/NHLBI conducted studies - Reviews AE and adverse device effects to determine attribution to the device - Assists sites in evaluating the AE or any possible unanticipated adverse device effect (UADE) and communicates with the PI when there appears to be a concern - Works in a cath lab collecting documentation and data as well as collecting blood samples, etc. for individual studies - Coordinates activities related to tracking and management of AE, UADEs, and protocol deviations, providing summary reports to the regulatory team - Ensures incoming and historical documents are organized and filed appropriately and that the Investigator and Sponsor's regulatory record is complete and in compliance with FDA regulations, guidance, policies and procedures - Provides consultation and assistance to complete protocol lifecycle requirements (eg, continuing review applications, bioethics reviews, protocol amendments, applicable Data Safety Monitoring Board [DSMB] reviews), FDA Annual Reports, regulatory binder maintenance) - Ensures activities are conducted in a timely manner and in accordance with NIH policies and guidelines, as well as applicable IDE regulatory guidelines - Assists staff to ensure human subjects protection - Assists research staff in navigating requirements from various NIH departments for research collaboration approvals - Attends onsite in-person meetings and provides meeting minutes when necessary - Participates in the multi-disciplinary review of clinical research study documents - Serves as a liaison for investigators and other clinical regulatory staff providing regulatory guidance, review and expertise to ensure documentation conforms to applicable regulations device and guidelines - Adheres to standard operating procedures for quality control and monitors quality assurance standards - Assist in the collection and review of study-specific documentation for each protocol submitted under an IDE - Participates in interactions with regulatory designees and agencies on defined matters as needed

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