Job ID: req4618 Employee Type: exempt full-time Division: Clinical Monitoring Research Program Facility: Telework: US Location: USA The Frederick National Laboratory is 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. Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way. 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. 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. POSITION DESCRIPTION This Protocol Navigator (PN) position in the CMRPD is under the Regulatory Compliance and Human Subjects Protection Program (RCHSPP) in the Protocol Navigation and Protocol Development Program (PN/PDP). The PN/PDP provides protocol navigation and medical writing support to the National Institute of Allergy and Infectious Diseases (NIAID) Intramural Clinical Research Program for the Office of Clinical Research Policy and Regulatory Oversight (OCRPRO). The PN/PDP team is composed of medical writers and navigators who assist in all stages of protocol document development from study concept through initial approval. The PN works directly with allergy, immunology, and infectious disease investigators to facilitate the review and submission of complete, accurate, and comprehensive documents that meet applicable policies and guidelines. The PN and Medical Writer (MW) work closely together in the drafting and reviewing of the study documents. The PN manages the timelines and communications with the study teams and works on submissions to the various offices needed for study approvals. The navigational activities span a breadth of research areas and include interactions in which the PN needs to accurately interpret policy and how it applies to the study, skillfully relay the study issues, and seek accurate and timely responses from colleagues within RCHSPP such as the Clinical Safety Office, Regulatory Affairs Office, and Clinical Trials Monitoring Group, as well as NIAID/NIH bodies such as the Institutional Review Board (IRB) and Scientific Review Committees, with the overall goal of reducing administrative burden for study teams and expediting the numerous reviews required for initial approval and subsequent complex amendments. KEY ROLES/RESPONSIBILITIES As part of the Protocol Navigation/Protocol Development Program (PN/PDP), the Protocol Navigator II: Provides expertise in protocol development and implementation support for NIAID intramural research protocols conducted domestically and internationally Serves as the point-of-contact and project manager for an assigned portfolio of multiple protocols at various stages of initial development as well as amendments Orchestrates meetings with Principal Investigators (PIs) and other key research staff to identify the level of support needed, creating timelines and managing protocol start-up logistics Works directly with PIs and MWs on the design, plan, production, and revision of study documents, including applying clinical and regulatory knowledge to the review of protocol and informed consent documents and conveys timely and logical suggestions that align to current processes Assists research staff in navigating requirements for protocol approval; completes submissions to approving bodies (e.g., scientific review, IRB, and radiation safety), coordinates with PIs and MWs to ensure stipulations are addressed appropriately and promptly, and tracks the required approvals necessary to initiate intramural research Plans navigational activities to be conducted in a logical and timely manner and in accordance with policies and guidelines Prioritizes multiple studies and can shift from one project to another on a daily basis with ease Provides advice and assistance in troubleshooting human subjects protection issues Works closely with the 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 PN/PDP team members Collaborates and communicates with other divisions and individuals (regulatory associates, medical monitors, and site monitors) to identify the regulatory guidelines and required timelines for Food and Drug Administration (FDA) requisite activities, ensure protocol design safety issues are identified early, ensure required oversight is initiated and outlined in the protocol Has the ability to take in information from different sources, interpret how it applies to the study, and apply it to the relevant documents and then accurately and concisely relay actions and next steps Performs work independently under the general guidance of the supervisor Attends virtual and in-person meetings at the NIH campus in Bethesda, Maryland This position is currently remote, with potential for return to office 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 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 related experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency In addition to educational requirements, a minimum of two (2) years of progressively responsible experience in biomedical research, including a minimum of one (1) year directly related to overseeing multiple concurrent projects/protocols Must be proficient in regulatory and human subjects protection standards related to clinical research development and initiation of protocols at clinical sites Knowledge of regulatory requirements and guidelines for facilitating clinical human subjects research, including Health and Human Services (HHS) regulations Familiarity with protocol and informed consent documents, and approvals needed to initiate a study Ability to work in a clinical research regulatory setting, both independently and within a team, to coordinate, negotiate and facilitate the program goals Ability to independently assess project needs, mitigate potential pitfalls, confer with experts, and communicate and initiate a plan of action Strong collaborative skills with ability to build relationships within multiple groups Must be detail-oriented and possess substantial organizational skills Ability to exercise sound judgment in prioritizing multiple tasks and projects while establishing timelines, tracking milestones, and dealing with shifting priorities Ability to submit high quality deliverables in a professional environment under tight deadlines Ability to communicate effectively, orally and in writing, with non-technical and technical staff Proficiency in Microsoft Word including proficiency with track changes, MS Office Ability to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Familiarity with therapeutic area of allergy and infectious diseases Previous study coordination and/or project management experience in clinical research Registered Nurse (RN) Commitment to Non-Discrimination All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws. Pay and Benefits Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here 92,900.00 - 133,215.00 USD The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data. The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions