Sr. Research Nurse (International Health)

Responsibilities

• Planning and organizing implementation of research studies
• Developing or participating in the development of appropriate source documents
• Assisting with site logistics including resource needs
• Assisting with orientation and adherence of study staff to protocol
• Guiding study staff in the day-to-day operations of the study
• Oversight of data collection. Participation in weekly progress meetings
• Developing and maintaining manual of procedures for multiple research projects
• Developing SOPs and updating as needed
• Maintaining effective professional communication with project staff
• Providing clinical nursing care directly to adult study participants on an isolation unit
• 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)
• Acting as contact between temporary staffing agencies, outside agencies, institutional partners, CIR staff, and other agencies involved in these studies
• Screens, recruits, educates, obtains informed consent, administers study material, surveils, collects specimens, collects data, maintains volunteer medical and research records, maintains written study related logs, ships lists, and maintains drug accountability
• Administers study materials (i.e., vaccine or challenge preparation)
• Conducts studies within IRB, GCP, and HIPAA (if applicable) guidelines
• Ensures adherence to protocol, IRB, GCP, and HIPAA (if applicable) guidelines
• Provides input into operational project procedures
• Devises and implements quality control measures as needed
• Supervises casual nurses and research assistants
• Prepares and maintains inpatient unit for subject occupation
• Aids in regulatory processes (IRBs, FDA, etc.)
• Maintains awareness of overall development of clinical research in accordance with sponsor expectations and industry standards
• Participates in marketing, education, and outreach activities regarding protocol activities
• Attends and maintains 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

Qualifications

• 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
• Minimum of two years' experience in the specialty or a related area required
• 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