Sr. Research Nurse

This position is in the Center for Immunization Research (CIR), Department of International Health. We are seeking a Sr. Research Nurse who will coordinate and implement vaccine research protocols under direction of the Program Director and Principal Investigator. These trials are conducted in outpatient and inpatient settings.

Specific Duties & Responsibilities

• Responsible for planning and organizing implementation of research studies.
• Develop or participate in the development of appropriate source documents to assure accurate completion of case report forms.
• Oversight of adherence by staff to protocol.
• Oversight of data collection.
• Participate in, and organize, 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 healthy study participants.
• Identify and act upon impending changes in subject condition and care.
• Supervise and aid casual nursing and support staff in understanding and implementing the protocol.
• Responsible for screening, recruitment, education, obtaining informed consent, surveillance, collection of specimens, data collection including but not limited to study documentation, maintenance of participants medical and research records, maintenance of written study related logs.
• 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.
• Assist with regulatory process (IRBs, FDA, etc.).
• Responsible for 24-hour protocol accountability via CIR-issued cell phone and email.
• Participate in participant recruitment, education, and outreach activities regarding protocol activities.
• Review monitoring reports to identify deficiencies and corrects deficiencies with staff assistance.
• Holds self-accountable for professional, responsible conduct.
• Demonstrates excellent written, verbal, and interpersonal communication skills.
• Ability to work both as a member of a team and independently, exercises discretion and mature judgment, and manage multiple priorities simultaneously.
• Detail oriented, well-organized, self-motivated, superior time management skills.
• Attend training sessions for IRB updates, Human subjects' protection, HIPAA, DOT/IATA, CPR, Bloodborne Pathogens, and other trainings as required, along with renewals as required by sponsor or university.
• Assists in preparing of monthly, semiannual and annual reports to the study sponsor.
• Develops and implements data quality control plan and corrective action plans.
• Perform reasonable job duties as assigned by the Principal Investigator or Program Manager.
• Collects and documents laboratory specimens in compliance with assigned protocol.
• Transports, processes, and stores specimens according to protocol and regulatory guidelines.

Special Knowledge, Skills, & Abilities

• Must be able to communicate and interpret information to research subjects, medical providers, investigators, sponsors, and regulatory agencies.
• Must be able to present complex research data.
• Must be comfortable using Microsoft office software such as Word, Excel, and Outlook. Prefer proficiency with REDCap.
• Must be able to present complex research data.

Physical Requirements

• Must be able to provide first responder care in emergent situations, such as CPR.
• Must be willing to become certified as a clinical research professional within two years of hire.
• Must be able to use hands to take vital signs, administer medications, draw blood, and computer data entry.
• Must be able to move about the campus and to Bayview Medical Center to the isolation unit.
• Ability to transport specimens from the clinic in Hampton House to the research laboratory on Wolfe Street. Must be able to lift, carry, push, and pull up to 50 lbs.
• Must be able to provide first responder care in emergent situations, such as CPR.
• Must be willing to have twice yearly influenza vaccination as per study protocols.

• Individual must be a registered nurse, licensed in the Stat