Protocol Navigator II

About the role

The 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 team provides protocol navigation and medical writing support to the National Institute of Allergy and Infectious Diseases (NIAID) Intramural Clinical Research Program.

Responsibilities

• 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 Medical Writers (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
• Aids 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
• Manages 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 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
• Attends virtual and in-person meetings at the NIH campus in Bethesda, Maryland

Qualifications

• 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
• Proficient in regulatory and human subjects protection standards related to clinical research development and initiation of protocols at clinical sites
• 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
• Detail-oriented and possesses substantial organizational skills
• Able to exercise sound judgment in prioritizing multiple tasks and projects while establishing timelines, tracking milestones, and dealing with shifting priorities
• 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