Research Nurse (Oncology)

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