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Registered Nurse

Axle

Rockville, MD, USonsite

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About this role

(ID: 2026-2678)

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 Registered Nurse to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Allergy and Infectious Diseases (NIAID) located in Rockville, 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)

Position Information:

Under this Task Order, the contractor(s) shall provide services in support of the overall functions of the Autoimmunity and Mucosal Immunology Branch at the Division of Allergy, Immunology and Transplantation, NIAID. The Branch funds clinical observational studies and clinical trials in autoimmunity and primary immune deficiency. Branch staff work cooperatively with funded extramural investigators, clinical coordinators, CROs and other study personnel to support the development of study protocols, informed consent forms and other pertinent documents and continue to do so during the conduct of these studies. In this context, the contractor works closely with NIAID Physicians, Regulatory Officers and Pharmacists.

Additional Qualifications:

Certifications & Licenses

• RN, NP, PA or MD degrees (practicing license not necessary)

Field of Study

• Nursing

Software

• Current Good Clinical Practice training

Skills

• Experience in clinical data management.

• Familiarity with IRB requirements.

• Excellent writing skills.

Deliverables:

• Monthly status reports to include information on current and completed activities; problems encountered; corrective actions taken; and recommendations for the next reporting period.

• Report should be sent to the NIAID CMC Contracts Team and the Task Leader every month and include:

• Hours worked

• Status reports to assess progress, as requested by the Task Leader.

• Quarterly Report sent to COR, due within 15 days of the end of the reporting period, that includes the following for each specific contract employee for every month:

• Overtime

• Travel expenses

• Visa expenses

• Occupational Health expenses

• All deliverables shall be submitted to the NIAID CMC Contracts Team and to the Task Leader. - Ad-Hoc

Statement of Work Details:

• Monitor integrity, completeness and timeliness of clinical data collection. - 1

• Problem-solve complex or unpredictable situations and improve processes and services to patients and colleagues. - 2

• Participate in clinical practice and research support meetings and develop multidisciplinary performance improvement programs and projects to improve operating procedures, patient care and decrease costs. - 3

• Monitor activities pertaining to clinical protocols such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing trials. - 4

• Develop and maintain internal documents for clinical trials not supported by Clinical Research Organizations. - 5

• Recruits and screens patients for inclusion in protocols and clinical trials.

• Participate in recruitment and outreach activities and contribute to recruitment strategies through innovative ideas.

• Design and maintain a selection of materials appropriate to send to health care referral sources seeking eligibility information or other objectives.

• Provide information about the study to referring physicians, advocacy groups, NIH offices, and in response to inquiries from potential study participants.

• Performs assessments and physicals, and collects medical histories.

• Manage clinical and research support activities to ensure patient safety and address the clinical needs of the patients.

• Administers protocol consents and documentation and monitors compliance.

• Ensure informed consent process and human subjects protection in clinical research and counsel patients regarding the potential risks.

• Collaborate with researchers and medical staff to obtain and maintain informed consent and assent and address ethical and legal implication of the research protocol.

• Contribute to all study related IRB and regulatory matters, including all reporting requirements (including deviations, unanticipated problems, adverse events) and report issues and variance promptly to the research team.

• Collect and report data to appropriate regulatory and monitoring agencies.

• Coordinate various activities to ensure proper and filing of serious adverse events, amendments, annual reports, and other regulatory documents.

• Prepare documentation and track and report regulatory and institutional protocol requirements and resolve all stipulations from protocol oversight groups.

• Performs data input and management.

• Participate in data analysis and management as well as manuscript preparation and presentation of findings.

• Support the general implementation, tracking, data acquisition, collection and reporting of all elements of the protocols.

• Provide expertise in clinical trial coordination and management of data acquisition.

• Review adverse event safety datasets, serious adverse events reports, external safety reports, and protocol deviations to ensure participant safety, data integrity and regulato

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