Sr. Research Nurse (Oncology)

Johns Hopkins University requires all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions may be provided for religious beliefs or medical reasons. Position: Sr Research Nurse. Reporting to the Senior Division Manager, Nurse Manager, and/or the Lead Research Nurse, this role is responsible for the coordination and implementation of assigned clinical trials within the 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 and local regulations when evaluating new protocols. Reviews and assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety, etc. Evaluates the impact on and availability of resources for assigned clinical trials. Lists and clarifies concerns and questions about new protocols with the PI and/or sponsor. Proposes and negotiates alternatives to improve protocol implementation. Pre-initiation Collaborates in determining roles and responsibilities of health care team members in the implementation of assigned trials. Collaborates in designing appropriate methods for data collection required for assigned trials. Obtains appropriate database/electronic data capture training and access. Oversees and collaborates in development of study tools including data collection forms, eligibility checklists, Beacon orders, and distribution of the protocol on the Web Library and Internet where applicable. Sets up and ensures appropriate research study accounts; reviews PRA. Ensures receipt of protocol and other manuals/documents to clinical CORES for review and input as appropriate. Ensures study documents are uploaded into PRL website for Beacon Treatment Plan development for both new submissions and amendments. Ensures compliance with local and national regulatory standards; as appropriate, prepares and submits required regulatory documents. Monitors IRB approval and requests for further information as appropriate. Determines 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. Ensures that all elements of a trial are in place before opening to accrual. Communicates with protocol sponsors, NCI, cooperative groups and may coordinate plans to address issues with the PI. Recruitment & enrollment 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. Ensures accurate recording and 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 and GCP standards. Performs and 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 and monitoring. Ensures correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc. are in the regulatory binder/files. Communications Communicates effectively with study team members, CORES, clinical staff, patients and families. Patient/Family Education Designs and 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. Staff Education With assistance, coordinates and/or presents continuing education and 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. 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 or publication. Clinical Practice Planning Identifies needs 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 and patient populations. Implementation Collaborates with the health care team to coordinate and facilitate protocol requirements and clinical care for assigned clinical trials. Begins to manage multi-modality trials utilizing current treatment modalities. Evaluation 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 the effectiveness of nursing care planned on a long-term basis. Gives rationale for action or 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 to facilitate clinical and research outcomes. Provides guidance and direction to other health care professionals in implementation of research protocols. Evaluates effectiveness of the collaborative role with other health care professionals. Minimum Qualifications Candidate must be a registered Nurse, licensed in Maryland or the state of practice. A Bachelor’s degree in nursing or related discipline is required. Minimum of two years’ experience in the specialty or a related area is required. Additional experience may substitute for bachelor’s degree and related master’s degree may be considered in lieu of experience. Preferred Qualifications Master’s Degree strongly preferred. Classified Title: Sr. Research Nurse Role/Level/Range: ACRP/04/MF Starting Salary Range: $75,100 - $131,700 Annually ($90,000 targeted; Commensurate with experience) Employee group: Full Time Schedule: Mon - Fri / 8:30am - 5p FLSA Status: Exempt Location: School of Medicine Campus Department name: SOM Onc Hematologic Malignancies Personnel area: School of Medicine The Johns Hopkins University is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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