The Department of Pediatrics seeks a Research Nurse Manager who will oversee the day-to-day operations of SMILE-TB, a multi-center, open-label, randomized, controlled, treatment-shortening noninferiority Trial at 7 sites in 6 high TB-burden countries in Africa and Asia. Supervision of Johns Hopkins based research-related staff, including research coordinators, assistants, regulatory specialists, etc. is required. Training and oversight of international study site team members remotely and onsite to meet project milestones and ongoing deadlines; international travel to sites to conduct site assessment, training and ongoing evaluation required. As a manager and coordinator, this individual will be responsible for maintaining regulatory compliance per Food and Drug Administration guidelines, Department of Health and Human Services guidelines, Good Clinical Practice guidelines, and ICH guidelines. This individual will have fiscal management of a $24 million budget across the 6 countries and 7 sites. Knowledge of HIPAA requirements and human subjects training is required. Requires experience working with complex clinical protocols including phase I-IV studies and protocol adherence issues.

Project Summary

The SMILE-TB study is funded by the U.S. Agency for International Development (USAID) through 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 is a grant-funded position through July 2027 contingent on the Agency’s continued support throughout the duration of the project period. SMILE-TB will occur at 7 clinical research sites across South Africa, Uganda, Mozambique, Zambia, Indonesia and India.

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 (Technical Area 1), new treatment drugs and regimens (Technical Area 2), socioeconomic and health system challenges (Technical Area 3), methods to interrupt TB transmission (Technical Area 4), and TB vaccines readiness and delivery (Technical Area 5). Technical Area 2 consists of four clinical trials for treatment and prevention of TB disease for both drug-susceptible and drug-resistant TB disease.

Specific Duties & Responsibilities

Leverage Staff

• Hire, train and supervise and conduct performance appraisals for JHU-based research support staff consisting of research coordinators, program coordinators, research assistants and other professional staff.
• Mentor, motivate and counsel/discipline as needed research support staff.
  
• Oversee progress of staff through weekly progress meetings.
  
• Lead interview, onboarding and orientation processes for new research staff.
  
• Arrange for adequate coverage when personnel are absent.
  
• Consult with Principal investigator, Department Director and Administrator to determine long-term staffing needs and level of expertise required by program goals and utilization trends.
  
• Primary point of contact for Clinical Research Units, Research Laboratory, Investigational Pharmacy, Research Finance and Divisional Administration.
  
• Create and implement training for JHU-based and international site-based research staff both remotely and on-site in international settings.
  
• Facilitate and ensure productive working relationships within SMILE-TB, TA2 and with each international research site to ensure smooth operation of clinical components, resolve issues as needed.

Assist Principal Investigator with development, management, coordination and compliance of SMILE-TB and TA2 activities

• Oversee project development, implementation and progress at JHU and each of the 7 international trial sites.
• Coordinate and lead monthly protocol team meeting and bi-monthly meetings with each site team and their respective local stakeholders.
  
• Leveraging clinical nursing and operational leadership experience to support development and ongoing review of study protocol, informed consent forms, other study related documents and supplies lists (clinical, administrative) to ensure safe and practical activation and ongoing study enrollment.
  
• Develop and maintain study specific clinical and administrative Manual of Operations and support teams in developing, reviewing and maintaining site-specific Standard Operating Procedures (clinical and administrative) as needed.
  
• Establish and implement processes and procedures within the research team to ensure compliance with the requirements of Johns Hopkins University, USAID and HHS guidelines, and all international non-Johns Hopkins research sites.
  
• Develop strategies and set target dates for goals.
  

Analyze data and develop reports and benchmarks to,

• Identify trends and patterns recruitment and retention of research subjects.
• Develop and monitor quality improvement initiatives.

• Engage the entire team in study outcome goals.
• Ensure that studies are conducted in accordance with all applicable US and relevant international regulations and guidelines and adhere to the standard operating procedures specified in USAID, JHU and site-level procedure manuals.
  
• Facilitate logistical aspects of materials, clinical supplies and services needed for projects.
  
• Develop JHU-based institutional review board (IRB) applications and US-based international regulatory agency applications.
  
• Develop and/or oversee development of international IRB/EC applications and international regulatory agency applications.
  
• Submit applications, amendments, annual renewals and other documents to the JHU IRB and other US-based regulatory agencies.
  
• Work with international sites to submit applications, amendments and annual renewals and other documents to their IRB/EC and regulatory agencies.
  
• Submit adverse event and study violation reports to the JHU IRB and other regulatory agencies.
  
• Work with international sites to submit adverse event and study violation reports to their IRB/EC and regulatory agencies.
  
• Develop and maintain Regulatory Binder and Manual of Procedures for SMILE-TB research project.
  
• Attend start-up meetings for new projects.
  
• Oversee auditing of compensations for study participants.
  
• Meet with Principal Investigator to discuss strategic planning for future research projects.

Provide clinical research coordination for the multi-center tuberculosis research projects

• Ensure international clinical trial research sites provide advanced clinical care directly to participants/families enrolled in SMILE-TB.
• Identify staff, participant and systems issues that impact participant care in the research setting.
  
• Develop and implement recruitment and retention strategies to ensure that studies are well-enrolled and have high participant retention rates, monitor progress toward recruitment goals and prepare progress reports.
  
• Liaise with, coordinate, and facilitate teamwork between pharmacy, laboratory, data, capacity building and community engagement managers at JHU coordinating center to effectively carry out the SMILE-TB study at international clinical research sites.
  
• Ensure accurate data management.
  
• Coordinate data being sent for independent review including data safety and monitoring board (DSMB), clinical and diagnosis endpoint review committee (CDERC), and independent radiology reads.
  
• Coordinate the SMILE-TB Clinical Monitoring Committee (CMC) including monthly meetings on study progress and “real-time” safety assessment/reporting.
  
• Coordinate with other TA2 studies to ensure consistency across all SMART4TB therapeutic trials.
  
• Prepare site and staff for auditing and monitoring visits; coordinate external and internal monitoring for each clinical research site.
  
• Support and provide staffing coverage for TA2 research nurse coordinators conducting SMART4TB clinical trials during planned and unplanned absences.

Budgeting & Compliance Reporting

• Support research operational processes including contracting, budgeting, donor reporting and communication, and award management tasks associated with project needs.
• Create and negotiate budgets with clinical research sites and USAID; fiscal oversight of the $24 million budget across six countries.
  
• Assist and oversee the grants and contract analyst to invoice for research-related costs.
  
• Assist, facilitate and provide oversight of material transfer agreements and data use agreements between research sites and contracted laboratory as well as research sites and JHU, respectively.
  
• Report progress of SMILE-TB study overall and by site to USAID quarterly or as requested by funder.
  
• Report progress on SMILE-TB to USAID missions and representatives from National Tuberculosis Programs (NTPs) with each site visit and/or as requested.
  
• Coordinate with other TA2 studies to ensure consistency for USAID reporting across all TA2 studies.

• 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. Master's degree strongly preferred.
• Minimum of five years experience in the specialty or a related area required.
• Related master's degree may be considered in lieu of some experience.

• Experience managing multi-disciplinary team members (e.g., nurses, administrative support staff) strongly preferred.
  

• Completion of School of Nursing Research Coordination training.
• Minimum of two years of experience working in the global south is preferred.
• Pediatric and/or adolescent clinical experience preferred.
• Pediatric phlebotomy experience/certification preferred.

Classified Title: Research Nurse Manager 
Role/Level/Range: ACRP/04/MG  
Starting Salary Range: $87,400 - $152,900 Annually ($135,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F; 8:30a - 5:00p 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM Ped Infectious Disease  
Personnel area: School of Medicine