Protocol Coordinator III
Job Description Within the Leidos Biomedical Research Inc.'s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) 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. JOB DESCRIPTION/BASIC FUNCTION The Clinical Monitoring Research Program (CMRP) provides regulatory and project management coordination associated with the clinical development and conduct of clinical trials in support to the Surgery Branch, Office of Protocol Support, Center for Cancer Research (CCR), National Cancer Institute (NCI). The Protocol Coordinator III: Provides programmatic and logistical support for the operations of clinical research Provides deployment of clinical support services for clinical research Streamlines the protocol development timeline Provides data and documents collection and compilation for regulatory filing with the Food and Drug Administration (FDA) and other regulatory authorities Provides technical review and report preparation Provides administrative coordination and general logistical support for regulatory activities Ensures the provision of training for investigators and associate staff to reinforce and enhance a Good Clinical Practices (GCP) culture Oversees quality assurance and quality control, performs regulatory review of clinical protocols, informed consent and other clinical documents Tracks and facilitates a portfolio of protocols through each process step (Institutional Review Board [IRB], Regulatory Affairs Compliance [RAC], Data Safety Monitoring Board [DSMB], Office of Protocol Services) Assists clinical investigators in preparing clinical research protocols, including writing and formatting consent forms Prepares protocol packages for review and ensures that protocol packages include all required material and complies with CCR, NCI and NIH policies Collaborates with investigators to resolve any protocol/data issues Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA Monitors the review process and maintains detailed, complete and accurate approval records for each protocol at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Attends and prepares minutes for the Branch Protocol Review Committees Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers, maintains records of these approvals and sends protocol amendments and other reports to the participating centers Maintains a schedule of all review committee submission deadline dates and meeting dates Assists clinical investigators in understanding and complying with the entire review process Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document and tracking system for NCI protocols Converts protocols from word format to .pdf with bookmarks and maintains the .pdf version of the most current approved version of each active clinical protocol on a central server 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 health/scientific, or medical related field (Additional qualifying experience may be substituted for the required education) Foreign degrees must be evaluated for US equivalency A minimum of nine (9) years of progressively responsible regulatory experience Knowledge of clinical trial fieldwork concepts and practices Well versed in FDA regulations, 21 CFR, and GCPs Knowledge of clinical research project implementation, with an understanding of project management, CRF and data collection/requirements, regulatory and quality assurance procedures and ICH guidelines Working knowledge of scientific principles Ability to exercise good judgment in planning and accomplishing goals Detail-oriented and strong organizational/planning skills with the ability to prioritize multiple tasks/projects Excellent written and verbal communication skills Must be able to obtain and maintain a clearance PREFERRED QUALIFICATIONS: Candidates with these desired skills will be given preferential consideration: Master's degree Immunology/Oncology experience Knowledge of clinical data report preparation Proficiency with Microsoft® software applications Ability to work in a clinical research setting both independently and within a team to build strong relationships with multiple groups Company Description Leidos is a global science and technology solutions leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company's diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.