The School of Medicine Pediatric Infectious Diseases is seeking a Sr. Research Nurse.  The Sr. Research Nurse is responsible for assisting with planning, implementing, and monitoring SMILE-TB while adhering to scope and timeline requirements, and assuring compliance with applicable regulations including GCP and ICH. They will be responsible for aspects of the implementation, management, and assessment of SMILE-TB and back-up other TA2 pediatric clinical trials. They will assist with: Manuals of Operations revisions and Standard Operating Procedures reviews; facilitate data management, data cleaning, and, occasionally, data analysis; prepare communications with institutional review boards; communicate with regulatory and funding agencies; other duties as assigned. They will plan and organize international activities, including fostering good communications and providing quality assurance for trials. International travel may be requested annually, depending on study progress and SMART4TB international team meeting locations. SMILE-TB clinical research site locations include South Africa, Uganda, Mozambique, Zambia, Indonesia and India.

Project summary

The U.S. Agency for International Development (USAID) launched the Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) project. SMART4TB, a five-year $200 million initiative, to identify more effective methods and tools for finding, treating, and preventing tuberculosis (TB) in 24 priority countries for TB programming. This initiative will build research capacity in high TB burden countries by supporting studies that evaluate novel approaches, interventions, and tools to combat TB–including diagnostic tests, new treatment drugs and regimens, socioeconomic and health system challenges, methods to interrupt TB transmission, and TB vaccines readiness and delivery.

Within SMART4TB’s Technical Area 2 (TA2) focused on new treatment drugs and regimens and under the supervision of the Research Nurse Manager, they will independently support and manage aspects of the scientific implementation and operation of the international, pediatric clinical trial “Shortened Regimen for Drug-susceptible TB in Children (SMILE-TB). This is a grant-funded position through July 2027 contingent on the Agency’s continued support throughout the duration of the project period.

Specific Duties & Responsibilities

• Prepare/review clinical trial documents including project agreements, CRFs and study plans/manuals, as appropriate.
• Coordinate operational aspects of clinical trials.
• Independently manage aspects of international clinical trial daily operations through to the final clinical study report.
• Monitor timelines and project deadlines and apply clinical and operational knowledge to evaluate study progress.
• Identify and anticipate potential study management or operations issues and collaborate with investigators and research staff to resolve these barriers to the study’s success.
• Coordinate review by the clinical diagnosis and endpoint review committee.
• Coordinate collection and cloud-based storage of digital x-rays from sites and review by central radiology team.
• Review and revise training materials, including site initiation visit materials, clinical examination-specific trainings, and other trial-specific training opportunities, in consultation with the Research Nurse Manager and trial investigators.
• Provide quality assurance oversight to preserve the rights and safety of research participants.
• Propose and negotiate alternatives to improve study enrollment as needed.
• Review trial operations to ensure that safety concerns and/or Adverse Events/SAEs and protocol deviations are properly reported and tracked.
• Apply clinical and operational knowledge to compile and present regular trial status updates to the Principal Investigator and Protocol Team.
• Review monitoring activities and escalate critical issues to the Research Nurse Manager.
• Collaborate with Contract Research Organization (CRO) monitors to foster a productive and effective working relationship.
• Conduct periodic review and revision of the Manual of Operations and site level SOPs to assure compliance with GCP and ICH policies.
• Assure compliance with regulatory requirements ensure that the clinical trial(s) is always “audit ready”. Ensure that any audit observations are addressed appropriately and in a timely manner.
• Maintain a platform for regular communication with the sites.
• Develop agenda for regular multi-site teleconferences; ensure timely preparation and distribution of meeting minutes.
• Prepare submissions to institutional review boards for study protocols, using IRB, and respond to queries, in consultation with the Research Nurse Manager.
• Contribute to the research team in preparing abstracts and presentations related to research projects.
• Attend virtual and in person meetings with site teams and the SMART4TB consortium.
• Perform other related functions, as assigned.

• Individual must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline required. 
• Minimum of two years experience in the specialty or a related area required.
• Additional experience may substitute for bachelor's degree and related master's degree may be considered in lieu of experience

• Pediatric and/or adolescent clinical experience.
• Two years of experience working in high TB burden countries.
• Master's degree strongly preferred.

Classified Title: Sr. Research Nurse 
Role/Level/Range: ACRP/04/MF  
Starting Salary Range: $75,100 - $131,700 Annually ($102,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F; 37.5 hours per week 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM Ped Infectious Disease  
Personnel area: School of Medicine