Job Description

The Department of International Health is seeking a Senior Research Nurse who will coordinate and implement vaccine research protocols for clinical trials involving vaccines, therapeutics, and controlled human infections, under direction of the Program Manager and Principal Investigator(s). These trials are conducted in outpatient and inpatient settings.

Specific Duties & Responsibilities:
Responsible for planning and organizing implementation of research studies in the following areas:
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 subject’s 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

Minimum Qualifications (Mandatory):
Bachelor's Degree in Nursing or related discipline required.
Requires individual be registered nurse, licensed in the State of Maryland or state where practicing.
2 years’ experience in the specialty or a related area required.
Additional experience may substitute for Bachelor's Degree. Related Master's Degree may be considered in lieu of experience.*

* JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience.  Additional related experience may substitute for the required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

** Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Preferred Qualifications:
Previous clinical trial experience strongly preferred.
Experience with clinical laboratory procedures and oversight.
Master's degree strongly preferred.

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.
Must be comfortable using Microsoft office software such as Word, Excel, and Outlook.

Technical Qualifications or Specialized Certifications:
Must be able to provide first responder care in emergent situations, such as CPR.

Other Requirements:
Should have the flexible work schedule to accommodate needs of the project and transportation to travel off-site to satellite sites.

Physical Requirements:
Must be able to use hands to take vital signs, administer medications, draw blood, and computer data entry.
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.