Clinical Research Nurse (Pediatric Infectious Diseases)

The Eudowood Trials Network researchers conduct pediatric focused clinical trials and clinical studies that promote access to innovative therapeutics and diagnostics; effectively advancing pediatric clinical care and treatment in the specialty populations of infectious disease, pulmonology, and neonatology.

We are seeking a Clinical Research Nurse to oversee the day-to-day activities of multiple government funded and pharmaceutical research trials and make independent decisions that impact the conduct of the research.

The Clinical Research Nurse will work collaboratively with a multidisciplinary health care/research team to promote quality and excellence of care, optimize team performance, and achieve divisional clinical, research and organizational goals and outcomes.

Specific Duties & Responsibilities

Work on complex clinical studies which require a high level of knowledge, coordination and data abstraction.

Maintain good working knowledge of all assigned protocol and reporting requirements.

Screen potential participants for participation in trials and recruitment for studies through patient registries and relevant clinics.

Direct the research staff and coordinate activities of the study visit at the clinical research unit, mobile research van, community venues, and participant homes.

Evaluate ongoing eligibility of research subjects participating in clinical trials; collaborate with principal investigator to obtain exceptions as appropriate.

Evaluate the effectiveness of nursing care given on a short-term basis.

Ensure the informed consent process for studies is completed, and coordinate participant enrollment and follow-up visits related to each respective study.

Assesses and ensures subject safety throughout participation in the trial and assists patients with medical problems related to study.

• Recognizes common laboratory values and alerts appropriate individuals for clinically significant deviations.
• Presents PI with relevant information for determination of seriousness, causality, and intervention for adverse events.
• Acts on the PI’s recommendation for adverse event intervention.
• Maintain follow-up to determine resolution of adverse events.
• Will recognize and document adverse events per protocol and ensure reporting to the appropriate study and regulatory personnel, as well as initiate adverse events reports and ensure proper and timely distribution to sponsor and IRB.
• Attend medical staff meetings to review study progress.

Responsible for appropriate documentation of clinical study in medical records and appropriate protocol documents. Schedules visits, tests & procedures for patients entered clinical trials to ensure results are available in a timely manner.

Will assist with the management of protocol related health problems and maintain communication with members of the research team in a confidential manner and in accordance with good clinical practice.

Communicates data from clinical trials relevant to patient management to community-based health care personnel.

Maintaining research related documents and correspondence in a confidential manner, including informed consent forms and research data.

Collaborate with other members of the research team to prepare for and respond to study audits.

Will assist with the collection and management of study data and bio specimens, entering data into study database(s), as well as documenting and reporting adverse events.

Resolving queries and reviewing monitoring reports to identify and correct errors Reporting protocol deviations and adverse events in a timely manner.

• Maintaining study inventory according to regulatory standards.
• Reviewing research accounts status with PIs.
• Will meet with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the sponsor as defined in the financial contract.
• May participate in the development of invoicing schedules.
• Working with Compliance committees and Institutional Review Boards.

Ensures development and or availability of appropriate protocol and or treatment specific patient education materials.

Determines effectiveness of patient/family education and modifies the education plan to most effectively address patient/family needs.

Provide staff education related to assigned clinical trials (in-services).

Attend and participate in in-services, external trainings, workshops, conferences and other relevant and or required programs for professional growth and development.

Minimum Qualifications

Individual must be a registered nurse, licensed in the State of Maryland or state where practicing.

Current CPR certification required. 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.
• Prior experience in study coordination.
• Proficiency with MS Office software and EPIC electronic medical record system.
• Classified Title: Research Nurse
• Job Posting Title (Working Title): Clinical Research Nurse (Pediatric Infectious Diseases)
• Role/Level/Range: ACRP/03/ME
• Starting Salary Range: $66,215 - $116,130 Annually ($86,000 targeted; Commensurate w/exp.)
• Employee group: Full Time
• Schedule: M-F: 8:30 to 5pm
• FLSA Status: Exempt
• Location: Hybrid/School of Medicine Campus
• Department name: SOM Ped Infectious Disease
• Personnel area: School of Medicine