Sr. Research Nurse (Oncology)

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.
  • Evaluates 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

• Registered Nurse, licensed in the State of Maryland.
• Two years of experience in the specialty or a related area.
• 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 ($105,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Mon - Fri/8a - 430p
FLSA Status: Exempt
Location: School of Medicine Campus
Department name: SOM Onc Upper Aerodigestive Cancer
Personnel area: School of Medicine