Research Nurse (Department of Medicine- Infectious Diseases)

Research Nurse (Department of Medicine- Infectious Diseases)

The Division of Transplant Surgery and the Department of Medicine's Division of Infectious Diseases Transplant Research Center (TRC) is seeking a Research Nurse to implement and oversee multiple single-center and multi-site national studies. Our primary research is related to the use of novel organ sources to address the national organ shortage, such as organ donation from donors with HIV and hepatitis C. We are also studying COVID-19 in the transplant recipient population. The Research Nurse should be someone who works well in a fast-paced collaborative atmosphere but can also maintain a high degree of independence. The successful applicant will be passionate about participant well-being and improving the long-term trajectory for those participants through research and clinical care.

Specific Duties & Responsibilities

Study Management: Pre-Study

• Anticipates research requirements for designated patient populations.
• May collaborate in the development and writing of protocols and consent forms, as appropriate.
• Collaborates in the development and preparation of regulatory documents and IRB submissions, as appropriate.
• Lists and clarifies concerns and questions about new protocols with Sr. Research staff and PI.
• Proposes and negotiates alternatives to improve protocol implementation.

Study Management, Pre-Initiation

• Collaborates in the design of appropriate methods for the collection of data required for assigned trials.
• Ensures compliance with local and national regulatory standards.
• Collaborates with the study team and pharmacy to prepare drug data sheets for new trials.
• Monitors for and notifies PI of IRB approval/request for further information.
• Ensures that all elements of a trial are in place before opening for accrual.
• Participates in communications with protocol sponsors and cooperative groups, and coordinates plans to address issues with the PI.

Study Management, Recruitment & Enrollment; Data Collection & Document Maintenance

• Collaborates in the recruitment of participants within the protocol timeframe.
• Ensures collection of pertinent data from internal and external sources, and monitors compliance with requirements of assigned clinical trials.
• Ensures all protocol deviations are communicated to the study team for proper documentation and/or submission to regulatory agencies.
• Performs or schedules study-related tasks and procedures, such as investigational product administration/dispensation, phlebotomy, blood processing and shipping, urine collection, and vital signs, as outlined by the study protocol.

Evaluation & Oversight

• Provides nursing and research support on clinical studies while adhering to all protocol mandates.
• Coordinates with clinical teams to ensure adherence to a standard of care clinical practice. Evaluate participants' response to interventions/study medications, including toxicities, dose modifications, dose levels, and adverse reactions; propose alternative methods to meet individual participant needs.
• Applies clinical/pharmacological knowledge to assist the investigator in determining adverse event causality and relationship to the study drug/procedure.
• Evaluates participants' participation in assigned clinical trials and identifies barriers to compliance.
• Gives rationale for action/interaction based on scientific principle, practice experience, and internal/external regulation.
• Oversees the preparation of orders by physicians to ensure protocol compliance is maintained and submits orders to obtain clinical research samples as outlined in the protocol.
• Educates participants and families on protocol structure, study procedures, and study medication, ensuring understanding and adherence.
• Participates in the informed consent process.

Quality Assurance

• Assists with the development and review of TOID SOPs for the performance of clinical research.
• Maintains records of correspondence (faxes, e-mails, IRB submissions, FDA submissions, etc.).

Other

• Demonstrates ability to manage multiple projects at different stages of the clinical research process. Demonstrates ability to integrate new clinical trials with current research activity.
• Collaborates with other members of the research team in preparing study results for presentation/publication.
• May have the opportunity to author/coauthor manuscripts for publication and/or presentation at conferences related to areas of expertise.

Minimum Qualifications

• Individual must be a registered nurse, licensed in the State of Maryland.
• Current CPR certification.
• Must maintain current licensure and certification during duration of employment.
• Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Bachelor's Degree in Nursing or related discipline.