Senior Irb Jobs (NOW HIRING)

The Sr.i Research Nurse provides research coordination in support of the Center for Immunization Research. This position will include the opportunity to work with all facets of conduct of early phase vaccine inpatient and outpatient trials, including working within FDA regulations and ICH-GCP guidelines. The primary responsibilities include implementing inpatient and outpatient clinical studies in various vaccine research protocol(s), primarily in diarrheal disease, under the direction of the Principal Investigator and if applicable, the Research Nurse Manager.

Specific Duties & Responsibilities

• Responsible for planning and organizing implementation of research studies in the following areas;
• Protocol development
• Development, or participate in the development of appropriate source documents to assure accurate completion of case report forms
• Assist with site logistics including resource needs
• Assist with orientation and adherence of study staff to protocol
• Guide study staff in the day to day operations of the study
• Oversight of data collection.
• Participate in weekly progress meetings.
• Develop and maintain manual of procedures for multiple research projects.
• Develop SOPs and update as needed.
• Maintain effective professional communication with project staff and communicate status of research to Principal Investigator, investigators and study team.
• Provide clinical nursing care directly to adult study participants on an isolation unit at the Johns Hopkins Bayview campus.
• Identify and act upon impending changes in subject condition and care.
• Supervise and aid temporary nursing and support staff in understanding and implementing the protocol.
• Identification of resource needs (human, timelines, and facilities) and act as contact between temporary staffing agencies, outside agencies, institutional partner, CIR staff, and other agencies involved in these studies.
• Responsible for screening, recruitment, education, obtaining informed consent, administration of study material, surveillance, collection of specimens, data collection including but not limited to study documentation, maintenance of volunteer medical and research records, maintenance of written study related logs, shipping lists, and drug accountability.
• Administer study materials (i.e., vaccine or challenge preparation)
• Conduct studies within IRB, GCP, and HIPAA (if applicable) guidelines
• Ensure adherence to protocol, IRB, GCP and HIPAA (if applicable)
• Ascertain that study staff are working within IRB, GCP, and HIPAA (if applicable) guidelines.
• Provide input into operational project procedures.
• Responsible for ongoing quality assurance and quality control of protocols, day-to-day operations of the study, and data management.
• Devise and implement quality control measures as needed.
• Supervise casual nurse (s) and research assistants.
• Prepare and maintain inpatient unit for subject occupation, including, but not limited to:
• Security
• Food/beverages
• Linens
• Entertainment
• Housekeeping
• Assist with regulatory process (IRBs, FDA, etc.).
• Responsible for 24-hour protocol accountability via CIR-issued cell phone and email.
• Maintains awareness of overall development of clinical research in accordance with sponsor expectations and industry standards.
• Participate in marketing, education, and outreach activities regarding protocol activities.
• Attend and maintain mandatory training including but not limited to IRB updates, protocol site initiation, CPR renewals, biohazard, safety and human subjects training.
• Reviews monitoring reports to identify deficiencies and corrects deficiencies with staff assistance.
• Must maintain current certification/training requirements during employment:

• Biohazard materials training/Blood Borne Pathogen

• IATA
• CPR
• Human Subjects
• Nursing Licensure
• SOCRA or ACRP certification

Candidate must be able to occasionally travel off-site and to satellite sites. Ability to flex hours (including evenings, nights and weekends) to accommodate protocol needs is preferred.

• Individual must be a 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.

• 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.

Classified Title: Sr. Research Nurse
Role/Level/Range: ACRP/04/MF
Starting Salary Range: $36.10 - $63.31 HRLY (Commensurate w/exp.)
Employee group: Casual / On Call
Schedule: Days and hours may vary
FLSA Status:Exempt
Location: School of Public Health
Department name: Ctr for Immnztn Rsch Vaccine Scis CIR
Personnel area: School of Public Health