Clinical Research Protocol Navigator - Axle
Bethesda, MD
About the Job
(ID: 2024-5085)
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Clinical Research Protocol Navigator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Neurological Disorders and Stroke (NINDS) located in Bethesda, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overall Position Summary and Objectives The primary role for this Protocol Navigator (PN) position is to provide clinical research regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned. This role is centered around clinical research protocol and informed consent document development and requires expert writing skills. This role also includes IRB submissions, regulatory document management, amongst other regulatory study tasks.
Deliverables:
- Work products and documents related to protocol writing and editing; prepare amendments and all necessary forms; develop clinical research and clinical trial protocols, informed consent documents and other regulatory or study-related documents with special attention to the accuracy, consistency, and completeness of documents as well as proper format, spelling, and grammar (in conjunction with the PI and other relevant experts). - Daily
- Work products and documents related to developing clinical documents; review and ensure that protocols and consents meet regulatory requirements and are written in a guideline compatible format. - Ad-Hoc
- Work products and documents related to collaborating with staff on safety, regulatory and monitoring entities; coordinate with staff to integrate and ensure consistency of new/revised documents. - Ad-Hoc
- Work products and documents related to managing, tracking and coordinating regulatory activities for the study protocols, under the guidance of the PIs, from conception/development, through the protocol lifecycle, to study closure. - Ad-Hoc
- Work products and documents related to maintaining all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial; work with staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies. - Ad-Hoc
- Work products and documents related to the organization of regulatory protocol meetings and/or reports; interact closely with the clinical research team and other branch/section staff involved in protocol management; guide the protocol navigation process. - Daily
Work Details:
- Develop and review completed new and amended clinical research protocols and related documentation throughout the lifecycle of the study, with special attention to the accuracy, consistency, and completeness of documents. 1
- Develop new and review completed clinical research informed consent and other ethics and regulatory related documentation. 2
- Prepare new and review completed study reports and status updates, including amendments, audits and other administrative documentation. 3
- Develop new and review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports. 4
- Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports. 5
- Assists researchers with protocol development, assembly and review of clinical trial documents.
- Assist researchers develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts.
- Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids.
- Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.
- Assist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation.
- Assists researchers to develop initial and amended clinical research protocols and related documentation throughout the lifecycle of the study, with special attention to the accuracy, consistency, and completeness of documents.
- Assists researchers develop and maintain trial related documents and operational procedures.
- Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
- Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
- Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.
- Assist researchers prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
- Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies.
- Maintains study databases and conducts basic analysis.
- Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals.
- Assist researchers prepare, review and submit clinical data to monitoring agencies.
- Assists researchers collect, distribute and file regulatory documents.
- Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
- Organize quality assurance activities with pertinent regulatory bodies such as FDA, NIH, pharmaceuticals and others.
- Assist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval.
- Assist researchers prepare submissions to regulatory bodies in support of clinical trials.
- Provides technical support to researchers and the clinic.
- Work with the NINDS Clinical Trials Unit CTU and NINDS staff on the development and preparation of standard operating procedures SOPs pertaining to protocol navigation and regulatory writing for the NINDS Intramural Research Program
- Prepare draft documents for senior staff review
- Coordinate with other offices eg, Office of Human Subjects Research Protections, Office of Regulatory Support and Compliance, NINDS and NIH offices involved in communication to integrate and ensure consistency of new revised documents with policies
- Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, NINDS Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities
- Attend in-person meetings located at the NIH campus in Bethesda or virtual meetings, including weekly CTU staff meetings, protocol development meetings, research coordinator forum meetings, as well as regular research team meetings
- Develops and assembles clinical trial documents.
- Develop protocol documentation including schemas, patient calendars and teaching aids.
- Prepare study reports and status updates, including amendments, audits and other administrative documentation.
- Prepare IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
- Develop clinical research informed consent and other ethics and regulatory related documentation description
- Develops and maintains trial related documents and operational procedures.
- Collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
- Maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
- Write and edit study protocols, and amendments, reviews, reports, and other necessary forms.
- Prepare and support submission of study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
- Track and review adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.
- Collects and distributes regulatory documents.
- Review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
- Organize quality assurance activities with pertinent regulatory bodies such as audits by FDA, NIH, pharmaceuticals and others.
- Prepare researcher communication with IRB and NIH Clinical Center for protocol approval.
- Prepare submission documentation for regulatory bodies in support of clinical trials.
- Manage, track and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
- Develops, assembles and reviews clinical trial documents.
- Develop new and review completed internal research proposals, abstract submissions, poster presentations and manuscript drafts.
- Collects, distributes and files regulatory documents.
- Develop and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
- Conduct quality assurance activities in preparation for regulatory audits by FDA, NIH, pharmaceuticals and others.
- Communicate with IRB and NIH Clinical Center for protocol approval.
- Prepare and submit documentation for regulatory bodies in support of clinical trials.
- Manage, track and report regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
- Reviews and recommends changes to clinical trial documents.
- Review completed protocol documentation including schemas, patient calendars and teaching aids and recommend changes.
- Review completed clinical research informed consent and other ethics and regulatory related documentation and recommend changes.
- Review completed standard operating procedures (SOPs) for the clinical study and recommend changes.
- Review completed study reports and status updates, including amendments, audits and other administrative documentation and recommend changes.
- Review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports and recommend changes.
- Reviews clinical research protocols and related documentation throughout the developmental process, and prior to submission for accuracy, consistency, and completeness and recommends changes as needed.
- Reviews and maintains trial related documents and operational procedures.
- Maintain all study documentation to include investigator qualifications, trial logs, and safety reports and review for accuracy and completeness.
- Review records of all protocols and study applications, safety reports, annual reports and correspondence for accuracy and completeness.
- Review study protocols, and amendments, reviews, reports, and other necessary forms for accuracy and completeness.
- Review for accuracy and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
- Review for accuracy and completeness adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.
- Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports and review for accuracy and completeness.
- Collects, distributes and submits regulatory documents.
- Develop and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
- Conduct quality assurance activities in preparation for regulatory audits by FDA, NIH, pharmaceuticals and others.
- Communicate with IRB and NIH Clinical Center for protocol approval.
- Prepare and submit documentation for regulatory bodies in support of clinical trials.
- Manage, track and report regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
- Work 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,
- Develops training plans and trains staff on the proper techniques for protocol submission.
- Maintain documentation of clinical research training of staff.
- Meet with investigators and advise them of the documentation and approvals they will need to initiate a clinical study based on the type, location and complexity of the proposal.
- Educate 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 transfer.
- Organize regulatory protocol meetings and/or reports, as well as attend other research team staff meetings; interact closely with the research clinical team and other staff involved in protocol management; guide the protocol navigation process.
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Minimum Education
Masters
Additional Qualifications:
- Association of Clinical Research Professionals Certified Professional (ACRP-CP)
- Association of Clinical Research Professionals (ACRP)
- Certified Clinical Research Professional (CCRP)
- Certified Clinical Research Coordinator (CCRC)
- Certified Clinical Research Associate (CCRA)
Field of Study
- Miscellaneous Health Medical Professions
- Nursing
- Biology
- Multi-Disciplinary or General Science
- Health and Medical Preparatory Programs
- General Medical and Health Services
- Neuroscience
- Health and Medical Administrative Services
- Cognitive Science and Biopsychology
- Miscellaneous Biology
Software
- Clinical Trial Management System (CTMS)
- Electronic Medical Records System
- Electronic Data Capture System
Skills
- Liaising with regulatory authorities
- Training clinical trial site staff
- Previous clinical trial work
- Phase I or II experience
- Regulatory compliance
- Protocol development
- Protocol navigation
- Regulatory affairs
- Clinical Research
- IRB submissions
- Clinical Trials
- On-site visits
- Data Integrity
- Research
- ICH/GCP
- Strong writing skills with experience writing clinical research protocols
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location.
