Sr. Research Nurse (International Health)

Johns Hopkins University•Baltimore, MD

1d•$36 - $63•Onsite

About The Position

The Department of International Health at the Johns Hopkins Bloomberg School of Public Health is seeking a Sr. Research Nurse to provide research coordination in support of the Center for Immunization Research. This position offers the opportunity to work with all facets of early phase vaccine inpatient and outpatient trials, adhering to FDA regulations and ICH-GCP guidelines. The primary responsibilities include implementing inpatient and outpatient clinical studies in various vaccine research protocols, mainly in diarrheal disease, under the direction of the Principal Investigator and, if applicable, the Research Nurse Manager.

Requirements

Registered nurse, licensed in the State of Maryland or state where practicing.
Bachelor's degree in nursing or related discipline required.
Current CPR certification required.
Must maintain current licensure and certification during duration of employment.
Minimum of two year's experience in the specialty or a related area required.
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.
Must maintain current certification/training requirements during employment: Biohazard materials training/Blood Borne Pathogen, IATA, CPR, Human Subjects, Nursing Licensure.
Ability to occasionally travel off-site and to satellite sites.

Nice To Haves

Master's Degree strongly preferred.
Licensed in a Compact state.
Willingness to become research certified.
Previous inpatient or outpatient clinical research experience.
Phlebotomy and Intravenous (IV) skills.
Ability to flex hours (including evenings, nights and weekends) to accommodate protocol needs is preferred.

Responsibilities

Planning and organizing implementation of research studies, including protocol development.
Developing or participating in the development of appropriate source documents for accurate completion of case report forms.
Assisting with site logistics, including resource needs.
Assisting with orientation and adherence of study staff to protocols.
Guiding study staff in the day-to-day operations of the study.
Oversight of data collection.
Participating in weekly progress meetings.
Developing and maintaining manuals of procedures for multiple research projects.
Developing SOPs and updating them as needed.
Maintaining effective professional communication with project staff and communicating research status to the Principal Investigator, investigators, and study team.
Providing clinical nursing care directly to adult study participants on an isolation unit at the Johns Hopkins Bayview campus.
Identifying and acting upon impending changes in subject condition and care.
Supervising and aiding temporary nursing and support staff in understanding and implementing the protocol.
Identifying resource needs (human, timelines, and facilities) and acting as a contact between temporary staffing agencies, outside agencies, institutional partners, CIR staff, and other agencies involved in these studies.
Screening, recruitment, education, obtaining informed consent, administration of study material, surveillance, collection of specimens, data collection, maintenance of volunteer medical and research records, maintenance of written study-related logs, shipping lists, and drug accountability.
Administering study materials (e.g., vaccine or challenge preparation).
Conducting studies within IRB, GCP, and HIPAA (if applicable) guidelines.
Ensuring adherence to protocol, IRB, GCP, and HIPAA (if applicable).
Ascertaining that study staff are working within IRB, GCP, and HIPAA (if applicable) guidelines.
Providing input into operational project procedures.
Ongoing quality assurance and quality control of protocols, day-to-day operations of the study, and data management.
Devising and implementing quality control measures as needed.
Supervising casual nurse(s) and research assistants.
Preparing and maintaining the inpatient unit for subject occupation, including security, food/beverages, linens, entertainment, and housekeeping.
Assisting with the regulatory process (IRBs, FDA, etc.).
Responsible for 24-hour protocol accountability via CIR-issued cell phone and email.
Maintaining awareness of overall development of clinical research in accordance with sponsor expectations and industry standards.
Participating in marketing, education, and outreach activities regarding protocol activities.
Attending and maintaining mandatory training, including IRB updates, protocol site initiation, CPR renewals, biohazard, safety, and human subjects training.
Reviewing monitoring reports to identify deficiencies and correcting them with staff assistance.