Clinical Research Protocol Specialist

Frederick National Laboratory
Bethesda, MD
Nov 23, 2021
Nov 26, 2021
Analyst, Research
Full Time
PROGRAM DESCRIPTIONWithin Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD's mission has contributed to improving the overall standards of public health on a global scale.The Clinical Monitoring Research Program Directorate (CMRPD) provides regulatory guidance and assistance for protocol development, implementation, continuing support for intramural research protocols supporting the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), Office of Clinical Research Support within the Clinical Director's Office.KEY ROLES/RESPONSIBILITIESOrchestrates meetings with investigators and other key medical staff to identify required supportServes as the point-of-contact and project manager for an assigned portfolio of projectsWorks with PIs and the research team on the design, plan, production, and revision of study documents, including applying clinical and regulatory knowledge to the review of protocol and informed consent documentsWorks with research staff to navigate requirements for protocol approval and continued conduct: complete submissions to approving bodies (eg, scientific review, IRB and radiation safety), coordinate with PIs and the research team to ensure stipulations are addressed appropriately and on-time; track the required approvals necessary to initiate and continue intramural researchPrepares program actions that do not go to the IRB such as data sharing plans, reliance agreements and technology transfer agreementsProvides 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)Provides advice and assistance in troubleshooting human subjects protection issuesWorks with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments, and to share relevant information with Protocol Navigation (PN) and research team membersAssists the research study team with Investigational New Drug (IND)/Investigational Device Exemption (IDE) development and serial submissions to the US Food and Drug Administration (FDA); assists research staff in navigating requirements for special circumstancesWorks with the Office of Human Subjects Research Protection (OHSRP) to keep abreast of new guidance related to policy governing the conduct of research at the NIH Intramural Research Program, and to share relevant information with PN and research team membersEducates research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transferEnsures activities are conducted in a timely manner and in accordance with NIH policies and guidelines, as well as applicable IND/IDE regulatory guidelinesAttends NIDDK's Quality Assurance Program meetings, including site initiation visits and offers guidance regarding protocol preparationIdentifies and makes recommendations to improve the processes, procedures and policies of the Office and assist in issuing guidanceDisseminates expertise and best practices related to Human Protections in clinical re-search through presentations, publications, and/or interactions with colleaguesAttends meetings of various HRPP groups within NIHThis position is located in Bethesda, MarylandBASIC QUALIFICATIONSTo 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 or university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research, clinical trials, health or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for US equivalencyIn addition to education requirements, a minimum of five (5) years of progressively responsible experience in biomedical researchA minimum of four (4) years directly related to overseeing multiple concurrent projects that comprise diverse functions of clinical research implementation processes and conductMust be proficient in all functions of clinical research implementation processes and conductAbility to work in a clinical research setting both independently and within a team to coordinate, negotiate, and facilitate data and ensure documents are succinctKnowledge of regulatory requirements and guidelines for facilitating clinical human subjects research (including Department of Health and Human Services [DHHS] regulations)Familiarity with protocol and informed consent documents and approvals needed to initiate a studyAbility to prioritize multiple tasks and projects while establishing timelines, tracking milestones, and dealing with shifting prioritiesAbility to submit quality products under tight deadlinesProficiency in Microsoft OfficeMust be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projectsAbility to communicate effectively, orally and in writing, with non-technical and technical staffProficient in protocol and informed consent writingKnowledge of writing and submitting an investigational new device applicationAbility to obtain and maintain a security clearancePREFERRED QUALIFICATIONSCandidates with these desired skills will be given preferential consideration:Familiarity with therapeutic area of diabetes, digestive and kidney diseaseFamiliarity with FDA regulatory requirements for IND and IDE; preferably those related to investigational biologic agents regulated by the FDA, and guidelines for facilitating clinical human subjects researchKnowledge of International Conference on Harmonization/Good Clinical Practices and DHHS regulationsKnowledge of clinical trial designNavigation of protocol life cycle experience

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