Sr. Research Nurse (Oncology)

Johns Hopkins University•Baltimore, MD

18h•Onsite

About The Position

Reporting to the Nurse Manager and/or the Lead Research Nurse, this role is responsible for the coordination and implementation of assigned clinical trials within the Bayview Upper Aerodigestive Malignancies research program. The position involves project management from pre-study through data collection and quality assurance, patient and staff education, and clinical practice planning, implementation, evaluation, and consultation.

Requirements

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.
Related master's degree may be considered in lieu of experience.

Responsibilities

Collaborates in development and preparation of regulatory documents, including consent templating, eligibility checklists, and PK/VS/EKG sheets.
Applies knowledge of study design, federal, and local regulations to evaluate new protocols.
Reviews and assesses new protocols for clarity, thoroughness, logistical feasibility, and subject safety.
Evaluates the impact on and availability of resources for assigned clinical trials.
Proposes and negotiates alternatives to improve protocol implementation.
Collaborates in the determination of roles and responsibilities of health care team members.
Collaborates in the design of appropriate methods for data collection.
Obtains appropriate data base/electronic data capture training and access.
Oversees and collaborates in the development of study tools, including data collection forms, eligibility checklists, Beacon orders, and distribution of the protocol.
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 and input.
Assures study documents are uploaded into PRL website for Beacon Treatment Plan development.
Assures compliance with local and national regulatory standards; prepares and submits required regulatory documents.
May participate in drug data sheet development/review/revision.
Monitors for IRB approval/request for further information.
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.
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.
Ensures initial and ongoing eligibility of all subjects for assigned research studies.
Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes.
Applies pharmacological knowledge to assist the investigator in determining adverse event causality and relationship to study drug/procedure.
Assures accurate recording and documentation of protocol deviations.
Prepares and submits protocol amendments and revisions.
Manages multiple projects at different stages of the clinical research process.
Integrates new clinical trials with current research activity.
Monitors study team compliance with required study procedures and GCP standards.
Performs/monitors ongoing data analysis regarding clinical research studies, including toxicities, dose modifications, dose levels, adverse reactions, and 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.
Communicates effectively with study team members, CORES, clinical staff, patients, and families.
Designs/coordinates educational 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.
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 others involved in the research process.
Attends and participates in in-service and external trainings, workshops, conferences, and other relevant programs for professional growth and development.
Collaborates with other members of the research team in preparing study results for presentation/publication.
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.
Collaborates with health care team to coordinate and facilitate protocol requirements and clinical care for assigned clinical trials.
Manages multi-modality trials utilizing current treatment modalities.
Evaluates the effectiveness of nursing care 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.
Develops and maintains collaborative relationships with members of other health care disciplines.
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.