Sr. Research Nurse

We are seeking a grant-funded Sr. Research Nurse who will be supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB), a USAID-funded initiative to improve global TB control. The successful candidate will support PRISM Kids, a study evaluating new short course drug-resistant TB regimens in children. PRISM-Kids is a phase II, open-label, multicenter trial. The main objectives are to find out if treating children under age 14 years with DR-TB with and without HIV with a four to six month all-oral, once-daily regimen is safe and results in favorable TB-related outcomes at end of treatment and at week 52. Participants will be stratified at the beginning of the study on the basis of disease severity into one of two groups, a 4-month duration or a 6-month duration of treatment.

The Sr. Research Nurse is responsible for assisting with planning, implementing, and monitoring the PRISM-Kids trial, from protocol design to regulatory submissions to the final clinical study report, while adhering to scope and timeline requirements, and assuring compliance with applicable regulations including GCP and ICH. They will independently manage the scientific implementation and operation of PRISM Kids in concert with the study PIs and act as a liaison for the studies with the Protocol Team, international sites, regulatory agencies, study monitors, and administrators. They will be responsible for planning the implementation, management, and assessment of clinical trials led by investigators in the Center for TB Research. They will assist with aspects of protocol development, initiate and create case report forms, design Manuals of Operations, oversee implementation of Standard Operating Procedures at the site level, facilitate data management, data cleaning, and, occasionally, data analysis; prepare communications with institutional review boards, as well as communicating with regulatory and funding agencies, and other duties as assigned. They will plan and organize international activities, including fostering good communications and providing quality assurance for trials. International travel will be required several times annually, depending on study progress and international public health advisories.

Specific Duties & Responsibilities

• Contribute to the development of the PRISM Kids protocol, informed consents/assents, and clinical study reports; prepare/review clinical trial documents including project agreements, CRFs and study plans/manuals, as appropriate; and coordinate operational aspects of PRISM Kids
• Independently manage the implementation and daily operations from protocol design to the final clinical study report. Define timelines for study start-up and apply knowledge to evaluate progress.
• Maintain communications with a multi-disciplinary trial team made up of both internal and external team members, including but not limited to the study clinicians, site staff, contractual clinical monitor(s), vendors, data managers, and administrative staff.
• 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.
• Develop or oversee the development of training materials, including site initiation visit materials, clinical examination-specific trainings, and other trial-specific training opportunities, in consultation with investigators.
• Conduct at least quarterly in-person or virtual site visits to monitor operations and provide quality assurance oversight to preserve the rights and safety of research participants.
• Propose and negotiate alternatives to improve project implementation as needed.
• Provide overall management to ensure that safety concerns and/or Adverse Events/SAEs and protocol deviations are properly reported and tracked
• Coordinate with data management team to compile and disseminate regular trial status updates to the Principal Investigator and Protocol Team.
• Oversee monitoring activities and escalate critical issues to the Principal Investigator.
• Collaborate with Contract Research Organization (CRO) monitors to foster a productive and effective working relationship.
• Initiate and conduct periodic review and revision of the Manual of Operations and site level SOPs to assure compliance with GCP and ICH policies
• Develop agenda for regular multi-site teleconferences. Prepare and distribute meeting minutes in a timely fashion.
• Develop and maintain a platform for regular communication with the sites.
• Contribute to the research team in preparing abstracts and presentations related to research projects.
• Perform other related functions, as assigned.

Regulatory

• Implement a robust quality management system to ensure compliance with JHU and USAID require