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Sr. Research Nurse

Johns Hopkins University
United States, Maryland, Baltimore
Dec 20, 2024

We are seeking a Sr Research Nurse to work under the Nurse Manager and/or the Lead Research Nurse. This position is responsible for coordinating and implementing assigned clinical trials within the Breast Cancer and Female Malignancies research program.

Specific Duties & Responsibilities

Project Management

Pre-study

  • Collaborates in development and preparation of regulatory documents as appropriate including consent templating, eligibility checklist, PK/VS/EKG sheets.
  • Applies knowledge of study design to evaluate new protocols.
  • Applies knowledge of federal & local regulations when evaluating new protocols.
  • Reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety, etc.
  • Evaluate the impact on & availability of resources for assigned clinical trials.
  • Lists & clarifies concerns & questions about new protocols with PI &/or sponsor.
  • Proposes & negotiates alternatives to improve protocol implementation.


Pre-initiation

  • Collaborates in the determination of roles & responsibilities of health care team members in the implementation of assigned trials.
  • Collaborates in the design of appropriate methods for collection of data required for assigned trials.
  • Obtains appropriate data base/electronic data capture training and access.
  • Oversees & collaborates in development of study tools including data collection forms, eligibility checklists, Beacon orders, & distribution of the protocol on the Web Library and Internet (where applicable).
  • Sets up/assures set up of appropriate research study accounts/ reviews PRA.
  • Assures receipt of protocol and other manuals/documents to clinical CORES for review & input as appropriate.
  • Assures study documents are uploaded into PRL website for Beacon Treatment Plan development for both new submissions and amendments.
  • Assures compliance with local & national regulatory standards; as appropriate, prepares & submits required regulatory documents.
  • May participate in drug data sheet development/review/revision.
  • Monitors for IRB approval/request for further information as appropriate.
  • Determines that IRB approval has been received and study status is Active on CRO protocol library prior to initiation of research activity.
  • Represents department at research, investigator and protocol initiation meetings as required.
  • Assures that all elements of a trial are in place before opening to accrual.
  • Communicates with protocol sponsors, NCI, cooperative group and may coordinate plans to address issues with PI.


Recruitment & enrollment

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

Data collection/Document maintenance

  • Applies pharmacological knowledge to assist the investigator in determining adverse event causality & relationship to study drug/procedure.
  • Assures accurate recording & documentation of protocol deviations.
  • Prepares and submits protocol amendments and revisions as appropriate.
  • 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.

Quality Assurance

  • Monitors study team compliance with required study procedures & GCP standards.
  • Performs/monitors ongoing data analysis regarding clinical research studies, including toxicities, dose modifications, dose levels, adverse reactions, & response.
  • Participates in sponsor/cooperative group/internal audits/monitoring.
  • Assures correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc. are in the regulatory binder/files.

Communication

  • Communicates effectively with study team members, CORES, clinical staff, patients and families.


Patient/Family Education

  • Designs/coordinates educational education and tools for patients and families relevant to protocols.
  • Provides ongoing education to patients and families regarding pertinent clinical trial procedures and management of clinical care.

Staff Education

  • With assistance, coordinates and/or presents continuing education/in-service programs for Clinical Research Nurses, Clinical Nurses, Clinical Associates, Study Coordinators, Research/Standard of care Phlebotomists, and any others involved in the research process.


Professional Development

  • 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.


Clinical Practice

Planning

  • Identifies need and incorporates information from other health care disciplines into clinical research protocol.
  • Plans long-term study patient care in relation to identified and potential problems related to assigned research protocols/patient populations.


Implementation

  • Collaborates with health care team to coordinate and facilitate protocol requirements and clinical care for assigned clinical trials.
  • Begin to manage multi-modality trials utilizing current treatment modalities.

Evaluation

  • Evaluates the effectiveness of nursing care s/he has planned, administered, or delegated.
  • Evaluates patient's response to interventions outlined on study protocol.
  • Proposes alternative methods to meet individual patient needs and protocol requirements.
  • Evaluates effectiveness of nursing care planned on a long-term basis.
  • Gives rationale for action/inaction based on scientific principles, practice experience, and internal/external regulations.
  • Evaluates patients' participation in assigned clinical trials 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.
  • 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.


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 year's 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.

Classified Title: Sr. Research Nurse
Role/Level/Range: ACRP/04/MF
Starting Salary Range: $75,100 - $131,700 Annually ($103,400 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: M - F, 8:30 - 5:00 pm
Exempt Status:Exempt
Location:Hybrid/School of Medicine Campus
Department name: SOM Onc Breast & Gyn Malignancies Group
Personnel area: School of Medicine

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