Sr. Research Nurse (Oncology)

Johns Hopkins University•Baltimore, MD

2d•Onsite

About The Position

Reporting to the Senior Division Manager, Nurse Manager and or the Lead Research Nurse, we are seeking a Sr. Research Nurse who will be responsible for the coordination and implementation of assigned clinical trials within the research program.

Requirements

Individual must be a registered nurse, licensed in the State of Maryland
Minimum of two years experience in the specialty or a related area required.

Responsibilities

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.
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.
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.
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.
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.
Communicates effectively with study team members, CORES, clinical staff, patients and families.
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.
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.
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.
Begin to manage multi-modality trials utilizing current treatment modalities.
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.
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.