Sr Research Nurse (JHU Peds Neonatology)

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