Sr Research Nurse (JHU Peds Neonatology)

School of Medicine, Peds Neonatology is seeking an experienced Pediatric Sr. Research Nurse with the ability to manage research protocols in an intensive care environment, screen, consent and enroll patients, perform study regulatory functions, quality assurance, and work with and educate healthcare professionals from other disciplines in best practices in clinical research.

Specific Duties & Responsibilities

Project Management (30%)

Pre-study

• Anticipates research requirements for designated patient populations.
• Applies knowledge of study design and federal and local regulations to evaluate new study protocols.
• Collaborates in the development and writing of protocols, consent forms, and preparation of regulatory documents.
• Reviews and assesses new protocols for feasibility, and subject safety.
• Lists and explains concerns about new protocols with PI and /or sponsor.
• Proposes and negotiates alternatives to improve protocol implementation.
• Collaborates in the design of appropriate methods for collection of data required for protocols.
• Oversees and collaborates in development of study tools including data collection forms, eligibility checklists, surveys, questionnaires.
• Assists with preparation of budget for submission and coordinates study sponsor contract designation as appropriate.
• Assures compliance with local and national regulatory standards; prepares & submits required regulatory documents.
• Monitors for and notifies PI of IRB approval/request for further information as appropriate.
• Determines that IRB approval has been received prior to initiation of research activity.
• Represents research team at research and protocol initiation meetings.
• Assures that all elements of a protocol are in place before opening to accrual.
• Communicates with protocol sponsors, cooperative study group and coordinates plans to address issues with PI. Conducts qualitative and mixed- methods interviews and/ or surveys with local study participants.

Recruitment & Enrollment (20%)

• Ensures initial and ongoing eligibility of subjects for studies.
• Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes.

Data collection/Document maintenance

• Ensures collection of pertinent study data from source documents, and monitors compliance with requirements of study protocols.
• Records and documents protocol deviations
• . Prepares and submits protocol amendments and revisions to the IRB.
• Demonstrates ability to manage multiple projects at different stages of the clinical research process.

Quality Assurance (25%)

• Monitors study team compliance with required study procedures and GCP standards.
• Assists with ongoing data analysis regarding clinical research studies, including adverse reactions, and response.
• Assumes responsibility for specific QA activities for research teams.
• Participates in sponsor/cooperative group/internal audits/monitoring. Assists with development and review of institutional SOPs pertaining to performance of clinical research. Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc.

Communication

• Independently/collaboratively performs responsibilities.

Education (25%)

Patient/Family Education

• Designs/coordinates educational programs for patients and families relevant to protocols.
• Provides ongoing education to patients and families regarding pertinent protocol issues.
• Staff Education: Participates in orientation process for new Clinical Research Nurses and Clinical Associates, including mentoring and precepting.
• Coordinates and/or presents continuing education/in-service programs for NICU staff and faculty, clinical research nurses, clinical associates, data managers, and others involved in the research process.
• Attends and participates in in-service and external trainings, workshops, conferences, and other relevant programs for professional growth and development.

Community

• Collaborates with other members of the research team in preparing study results for presentation/publication.
• Given opportunities, authors/coauthors manuscripts for publication in the nursing literature and/or presentation at conferences related to areas of expertise.
• Identifies nursing research questions related to protocol populations/issues and, with assistance, collaboration, and appropriate financial support, implements nursing research within departmental priorities.
• Takes advantage of opportunities to make presentations in local community regarding research projects, areas of expertise.

Clinical Practice-Planning

• Identifies need and incorporates information from other health care disciplines into clinical research protocol.

Evaluation

• Evaluates patient response to interventions outlined on study protocol; proposes alternative methods to meet individual patient needs.
• Evaluates patients' participation in assigned protocols and identifies barriers to compliance.
• Plans, proposes and evaluates means to overcome identified barriers to protocol compliance.

Consultation

• Develops and maintains collaborative relationships with members of other health care disciplines in order to facilitate clinical and research outcomes.

Supervisory Responsibility

• Provides guidance and direction to other health care professionals (internal and external) in implementation of research protocols.
• Evaluates effectiveness of collaborative role with other health care professionals

Special Knowledge, Skills, and Abilities

• Ability to conduct qualitative interviews with families of seriously ill children.
• Excellent organizational, communication, and interpersonal skills, with sensitivity to issues of confidentiality, diversity, and participant safety.

• Individual must be a registered nurse, licensed in the State of Maryland
• Minimum of two year's experience in the specialty or a related area required.

• Master's Degree or Nurse Practitioners training preferred.
• Prior study coordination experience preferred.
• Proven ability to build and maintain collaborative relationships with diverse community partners, service providers, and research participants/families.
• Experience managing research operations such as IRB submissions, recruitment tracking, and data management systems.
• Proficiency with MS Office software and EPIC EMR preferred.

Classified Title: Sr. Research Nurse
Role/Level/Range: ACRP/04/MF
Starting Salary Range: $75,100 - $131,700 Annually (89,998 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M - F 8:30am - 5:00pm; some evenings/weekends may be necessary
FLSA Status:Exempt
Location: School of Medicine Campus
Department name: SOM Ped NICU
Personnel area: School of Medicine