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Job Req ID:  2662

Sr. Research Nurse

Role/Level/Range: ACRP/4/MF

Status: Full Time / Exempt

Salary Range: Competitive                                                     

Department: Oncology

School: School of Medicine

Work Location:  Washington, DC / Sibley Hospital

Work Schedule/Hours: Monday-Friday/8:30-5:00pm/37.5



Under the direct supervision of the SKCCC Oncology Research Nurse Manager, the Sibley Oncology Sr. Research Nurse is responsible for research activities of patients entered onto clinical trials at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Sibley Memorial.



Duties and Responsibilities:



  • Anticipates research requirements for designated patient populations.
  • Reviews and assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety.
  • Lists and clarifies concerns & questions about new protocols with PI &/or sponsor
  • Oversees and collaborates in the development of study tools including data collection forms, laboratory worksheets, eligibility checklists, preprinted orders.
  • Participates in study initiation meetings.
  • Prepares space for study-related equipment and supplies.


Study Conduct

  • Pre-screens potential research subjects for participation in clinical trials (incl. Review of medical history, concomitant meds, pathology, and other relevant documents).
  • Ensures insurance clearance requests are submitted and appropriate staff members are aware of insurance denials and follows up on status of appeals, etc.
  • Conducts and documents the informed consent process with subjects.
  • Ensures all required signatures are obtained on informed consent documents.
  • Ensures initial and ongoing eligibility of all subjects for assigned research studies.
  • Collaborates with the study coordinator in registering subjects to studies.
  • Obtains and ensures proper distribution of required pharmacokinetic samples.
  • Schedules, performs, and/or monitors procedures and tests, per protocol requirements.
  • Obtains required data through chart review, telephone communication, subject interview & assessment.
  • Ensures collection of pertinent data from internal and external.
  • Ensures correct documentation of clinical study activities in the medical record and appropriate protocol documents.
  • Monitors and ensures compliance with the protocol treatment and study schedule.
  • Monitors subjects for adverse events, reportable SAEs and grades identified toxicities per NCI or protocol-specific criteria.
  • Demonstrates knowledge of treatment modifications and protocol endpoints and monitors subjects for these.
  • Records and documents protocol deviations.
  • Provides study coordinator with timely data and prompt notification of SAEs, protocol deviations, treatment delays and end of treatment visits.
  • Communicates and collaborates with the PI, treating physician, study coordinator and other members of the study team on an ongoing basis regarding the implementation of the protocol and statuses of subjects.
  • Reviews protocol amendments to identify changes to treatment orders, study calendar and risks to subjects.
  • Communicates these changes to subjects, either verbally or through written re-consent, as determined by the IRB.
  • Maintains detailed working knowledge of all assigned protocols.


Clinical Practice

  • Organizes own time and sets priorities for a group of patients on a research protocol.
  • Demonstrates ability to manage multiple projects at different stages of the clinical research process.
  • Demonstrates ability to integrate new clinical trials with current research activity.
  • 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.
  • 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.
  • Complies with institutional infection control policies.
  • Documents the implementation of nursing care and patient’s response in accordance with the established standards of internal and external agencies.
  • Documents telephone and other communications with patients, per institutional policy.
  • Evaluates patients’ participation in assigned clinical trials and identifies barriers to compliance.
  • Plans, proposes and evaluates means to overcome identified barriers to protocol compliance.



  • Provides ongoing education to patients and families regarding pertinent clinical trial and clinical management issues.
  • Ensures development and/or availability of appropriate protocol- and/or treatment-specific patient education materials.
  • Determines effectiveness of patient/family education and modifies the education plan to most effectively address patient/family needs.
  • Identifies staff learning needs, including those based on requirements specific to designated research protocols.
  • Collaborates with health care team to coordinate and facilitate protocol requirements for assigned clinical trials.
  • Ensures development and 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 programs for professional growth and development.
  • Becomes highly knowledgeable concerning the structure and operations of the ETCTN/ACP2C, NCTN, the National Cancer Institute, and the relationship between these organizations and the Cancer Center and Johns Hopkins.
  • Maintains up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies. Demonstrate proficiency in research documentation standards.
  • Attends and participates in meetings of the research nurse group and other mandatory meetings to develop increasing knowledge of clinical trials
  • Completes required documentation for accreditation and annual reviews in a timely fashion.


Minimum Qualifications:

Individual must be a registered nurse, licensed in the State of Maryland or state where practicing.  Bachelor's degree in nursing or related discipline required. Master's degree strongly preferred.  Minimum of two years’ experience in the specialty or a related area required.  Additional experience may substitute for bachelor's degree and related master's degree may be considered in lieu of experience, to the extent permitted by the JHU Equivalency Formula.  Current American Heart Association or American Red Cross CPR certification required.  Must maintain current licensure and certification during duration of employment.  Acceptable completion of the JHH or BMC credentialing process is required within two weeks of start date. 


Preferred Qualifications:

Minimum of three years strongly preferred. Phase I clinical trial experience highly preferred.


Licensure, Certification, Registration:

  • Licensed Registered Nurse in the State of Maryland
  • Current CPR certification required.
  • Must maintain current licensure and certification during duration of employment
  • Completion of the JHH credentialing process is required prior to start date


Special Knowledge, Skills, or Abilities / Competencies:

  • Knowledge of research methodology and clinical research practices and principles.
  • Knowledge of investigational therapies which require special expertise and clinical care management.
  • Highly effective verbal and written communication skills are required
  • Ability to follow multiple, detailed directions of various protocols.
  • Ability to handle multiple and competing priorities.
  • Excellent organizational skills, attention to detail, and time management skills.
  • Ability to work independently.
  • Demonstrated knowledge of computer applications, databases, web-based systems, and Microsoft Office and personal computer systems.


Working Conditions:

  • Possible exposure to communicable diseases, hazardous materials, radiation, and pharmacologic agents.  Safety regulations must be followed.
  • Work schedules are determined by protocol activity and may demand flexible and/or extended work hours.


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 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



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