As part of a study team, the research nurse will manage and coordinate study-related activities for industry-sponsored clinical trials in Ataxia-Telangiectasia (an inherited disease causing neurodegeneration, immunodeficiency, cancer predisposition, and metabolic syndrome) within the Division of Pediatric Allergy & Immunology. The research nurse will interact with participants and caregivers in an outpatient setting, gathering data from study visits and acting as participant liaison throughout the study. The research nurse will work closely with a senior research nurse.
Oversee project implementation and progress of clinical research trial.
Independently screen and recruit potential study participants
Assist with obtaining participant consent as part of research visits and monitor progress throughout visit while maintaining HIPAA compliance and confidentiality.
Schedule and conduct clinical trial visits, which include vital signs, phlebotomy, blood withdrawal and transfusion of autologous blood product.
Complete data collection forms and maintain study records, case report forms, regulatory binders, and databases in compliance with multiple study protocols.
Acquire and process clinical samples, including blood and urine samples, preparing them for testing and/or shipment, and maintain specimen-tracking data.
Applies physiological and pharmacological knowledge to assist the investigator in determining adverse event causality & relationship to study drug/procedure.
Prepare for and assist with sponsor monitoring visits.
Assures all clinical protocol deviations are communicated with team for proper documentation and or submission to regulatory agencies.
Communicate status of research activities to study team.
Ensure that studies are conducted in accordance with all applicable regulations and guidelines, adhering to the standard operating procedures specified in the procedure manuals and study protocols.
Write applications, amendments, annual renewals and other documents to the IRB and other regulatory agencies, ensuring prompt submission of time-sensitive documentation.
Establish and implement processes and procedures to assure compliance with the University sponsored and sponsoring agencies
Ensure HIPAA compliance
Provide education to families about clinical trials including necessary instructions for medications, treatments, and/or testing
Assist in the development of SOPs and update as needed.
Must be able to work independently and cooperatively as a team member.
Assist and support other staff when necessary
Assumes responsibility for professional development by:
Maintaining current licensure with the Maryland Board of Nursing
Completing necessary JH mandated updates for nursing compliance
Maintaining biannual BCLS certification
Completing necessary JH Office of Research Compliance Training certification including but not limited to the follow course modules: Human Subjects Research, Conflict of Interest, Privacy Issues Related to Research
Seeking out opportunities for relevant continuing education
Clinical Trial Visits
Patient education and follow up
Collect data through patient interviews including, but not limited to, past medical history, present illness, social history, family history, medication history.
Visit scheduling and follow up with participants/caregivers
Data Management and Source Documentation
Maintenance of study documentation and records
Data entry into central database
IRB applications, amendments, annual renewals and other documents for IRB and other regulatory agencies
Safety report management from DSMB
Management and dissemination of communications from sponsor and CRO
Participate in sponsor monitoring visits
Must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline preferred.
Minimum one year experience in pediatrics highly desired.
Minimum one year experience in clinical research preferred but not required.
Venipuncture and specimen collection experience preferred.
Special knowledge, skills, and abilities:
Well-organized and efficient with managing critical time points.
Detailed oriented, flexible, and able to manage multiple tasks.
Must have concise, clear and professional communication, verbal and written, as well as interpersonal skills.
Basic PC usage, Word, Excel, Outlook.
Familiarity with databases and accurate data entry.
Equipment, Machine, or Tool Requirements:
Use centrifuge to separate blood cells from serum, transfer to cryo-vials with proper labeling, then ship or freeze.
Technical qualifications or specialized certifications:
Individual must be a registered nurse, licensed in the State of Maryland or state where practicing.
Current American Heart Association or American Red Cross CPR certification required.
Must maintain current licensure and certification during duration of employment.
Acceptable completion of the JHH or BMC credentialing process is required within two weeks of start date.
Classified Title: Research Nurse Working Title: Research Nurse Role/Level/Range: ACRP/03/ME Starting Salary Range: $60,342 - $83,034 (commensurate with experience) Employee group: Full Time Schedule: M-F, 8:30 - 5:00 Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003081-SOM Ped Immunology Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
Equal Opportunity Employer Note: Job Postings are updated daily and remain online until filled.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.