This role involves the coordination and implementation of assigned clinical trials within the research program, reporting directly to the Research Nurse Manager. Key duties span project management from pre-study assessment through enrollment, data collection, maintenance of study documentation, and quality assurance activities like adverse event reporting.
Requirements summary
The minimum requirement is being a registered nurse licensed in the State of Maryland, with the possibility of substituting education for experience or vice versa based on institutional equivalency formulas. A Bachelor of Science in Nursing degree and prior Oncology experience are preferred qualifications.
Reporting to the Research Nurse Manager, we are seeking a Research Nurse who will be responsible for the coordination and implementation of assigned clinical trials within the research program.
Specific
Duties & Responsibilities
Project Management
Pre-study Anticipates research requirements for designated patient populations. With guidance, reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintenance of subject safety. With guidance, lists & clarifies concerns and questions about new protocols with PI and sponsor. Reviews prospective reimbursement analysis (PRA) as appropriate.
Pre-initiation As appropriate & with guidance, reviews consent forms prior to submission to the IRB.
With guidance, prepares other forms required for study initiation (pre-printed orders, eligibility checklists, etc.).
Determines that IRB approval has been received prior to initiation of research activity.
Participates in study initiation meetings.
Prepares space for study-related equipment & supplies.
Recruitment & enrollment Ensures initial & ongoing eligibility of all subjects for assigned research studies.
Screens potential research subjects for participation in clinical trials (incl.
Review of medical history, concomitant meds, pathology, other relevant documents).
Evaluates ongoing eligibility of research subjects’ participation in clinical trials; collaborates with Principal Investigator to obtain exemptions as appropriate.
Abstracts data from a variety of sources to complete pre-study work-up.
Demonstrates and participates in the informed consent process.
As appropriate, documents obtaining of informed consent in medical record.
Registers research subjects per sponsor guidelines.
In conjunction with PI, monitors protocol enrollment goals.
Demonstrates knowledge of protocol endpoint definitions.
In collaboration with healthcare team, evaluates potential subjects for research participation.
Data collection/Document maintenance Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials.
Obtains & ensures proper distribution of required pharmacokinetic & tissue samples.
Schedules, performs, and/or monitors procedures & tests per protocol requirements.
Ensures correct documentation of clinical study in medical record and appropriate protocol documents.
Schedules visits, tests & procedures for patients entered in clinical trials to ensure results are available in a timely manner.
As appropriate, ensures all required signatures are obtained on informed consent documents.
As appropriate, ensures validity of available informed consent documents.
Maintains CRMS data base for enrollment.
Reviews protocol amendments as required.
Develops procedure and collection forms for pharmacokinetic sampling.
With guidance & as dictated by research protocol, obtains required data through chart review, telephone communication, subject interview & assessment.
Coordinates with data managers to ensure delivery of trial data for inclusion into study files.
As appropriate, & with assistance as needed, orders required medical equipment & supplies.
Maintains working knowledge of institutional information systems for correctly scheduling clinical tests & procedures and extracting data.
With guidance, organizes own time & sets priorities for research-related functions.
With guidance, able to prioritize workload & manage multiple projects effectively.
Achieves and maintains a working knowledge of computer software specific to department, including word processing, e-mail & internet functions.
Aware of & knowledgeable about departmental Standard Operating Procedures.
Quality Assurance Evaluates outcomes of assigned clinical trials.
Recognizes and documents adverse events per protocol & ensures reporting to appropriate study & regulatory personnel; with guidance, initiates adverse event reports and ensures proper and timely distribution to sponsor and IRB.
Grades identified toxicities per NCI or protocol-specific criteria.
Attends medical staff meetings to review study progress.
In collaboration with other members of the research team, prepares for and responds to study audits.
Communication With guidance, assists in completion of annual periodic review of data for reporting to IRB, protocol sponsors, & cooperative groups.
Documents written & verbal communication with study contacts. communicates effectively with subject & family of active and prospective study participants.
Communicates effectively with members of the health care and research teams.
Meets regularly with other members of the research team to review protocol progress and data collection.
Attends and participates in meetings of the research nurse group; completes required documentation for accreditation and annual reviews in a timely fashion.
Attains proficiency in Web-based communication.
Demonstrates understanding of the rules for advertising for subject participation, where appropriate.
Education Ensures that patient and staff education needs are met with regard to assigned protocols. Ensures development and/or availability of appropriate protocol- and/or treatment-specific patient education materials. Determines effectiveness of patient/family education & modifies the education plan to most effectively address patient/family needs.
Staff Education Identifies staff learning needs, including those based on requirements specific to designated research protocols. Ensures development & availability of appropriate staff education materials. Provides staff education related to assigned clinical trials (i.e., in-services). Attends and participates in in service and external trainings, workshops, conferences, and other relevant and/or required programs for professional growth and development.
Clinical Practice
Planning Organizes own time & sets priorities for a group of patients on a research protocol.
Plans for research related activities while understanding patient’s current medical problems.
Utilizes available resources to meet patient care needs.
Utilizes health care team members in planning care.
Coordinates care that involves other health care disciplines or resources to provide continuity and assist in patient compliance with protocol requirements.
Implementation Assesses and ensures subject safety throughout participation in trial; assists patients with medical problems related to study.
Recognizes common laboratory values and alerts appropriate individuals for clinically significant deviations.
Presents PI with relevant information for determination of seriousness, causality, & intervention for adverse events.
Acts on the PI’s recommendation for adverse event intervention.
Maintains follow-up to determine resolution of adverse event.
As appropriate, performs phlebotomy per policy & procedures.
Complies with institutional infection control policies.
Documents the implementation of nursing care & patient’s response in accordance with the established standards of internal & external agencies.
Performs complex treatments correctly & safely.
Documents telephone and other communications with patients per institutional policy.
Evaluation Evaluates effectiveness of nursing care given on a short-term basis.
Consultation Communicates data from clinical trials relevant to patient management to community-based health care personnel.
Minimum Qualifications
Individual must be a registered nurse, licensed in the State of Maryland. Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
Bachelor of Science in Nursing Degree. Oncology experience. Classified Title: Research Nurse Role/Level/Range: ACRP/03/ME Starting
Salary Range
$64,600 - $113,300 Annually ($90,000-103,400 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: Mon - Fri / 830a - 5p FLSA Status: Exempt Location: School of Medicine Campus Department name: SOM Onc Hematologic Malignancies Personnel area: School of Medicine
