Sr. Research Nurse

Johns Hopkins University

Baltimore , MD

ID: 7092852
Posted: January 26, 2022
Application Deadline: Open Until Filled

Job Description

The Oncology Department is seeking a Senior Research Nurse who will report to the Principal Investigator(s) and to the Program Manager and will be responsible for the coordination and implementation of assigned clinical trials within the research program.



Specific Duties and Responsibilities:

Project Management

Pre-study: Anticipates research requirements for designated patient populations
May collaborate in development & writing of protocols and consent forms, as appropriate,
Collaborates in development and preparation of regulatory documents as appropriate
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
Oversees & collaborates in development of study tools including data collection forms, eligibility checklists, preprinted orders, & distribution of the protocol on the Web Library and Internet (where applicable)
Assists with preparation of budget for submission and coordinates study sponsor contract designation as appropriate
Provides copy of study and pre-printed data forms to Data Management office for review and approval as appropriate
Prepares GCRC and PCRU protocol submissions as appropriate
Assures receipt of protocol by pharmacy for review & input as appropriate
Communicates with coordinating center and provides necessary documentation (i.e., Cvs, 1572, lab licenses, normal values, IRB submissions, etc.) as appropriate
Assures compliance with local & national regulatory standards; as appropriate, prepares & submits required regulatory documents
Prepares drug data sheets for pharmacy and assures submission of same to CRO/IRB for assigned protocols as appropriate
Monitors for and notifies PI of IRB approval/request for further information as appropriate
Determines that IRB approval has been received prior to initiation of research activity
Represents department at research 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 coordinates plans to address issues with PI
Recruitment & Enrollment: Ensures initial & ongoing eligibility of all subjects for assigned research studies: Same as Level I.
Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes
Data Collection/Document Maintenance: Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials.
Applies pharmacological knowledge to assist the investigator in determining adverse event causality & relationship to study drug/procedure
Records & documents 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: Evaluates outcomes of clinical trials.
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
Assumes responsibility for specific QA activities for research teams (i.e., participates in institutional QA process)
Participates in sponsor/cooperative group/internal audits/monitoring
Assists with development & review of institutional SOPs pertaining to performance of clinical research
Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc.
Communication
Independently/collaboratively performs responsibilities of Level I


Education

Patient/Family Education
Designs/coordinates educational programs for patients and families relevant to protocols
Provides ongoing education to patients and families regarding pertinent clinical trial and clinical management issues
Staff Education
Participates in orientation process for new Clinical Research Nurses and Clinical Associates, including mentoring and preceptoring
Coordinates and/or presents continuing education/inservice programs for Clinical Research Nurses, Clinical Associates, Data Managers, and others involved in the research process
Attends and participates in inservice 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
Given opportunities, authors/coauthors manuscripts for publication in the nursing literature and/or presentation at conferences related to areas of expertise
Identifies nursing research questions related to protocol populations/issues and, with assistance, collaboration, and appropriate financial support, implements nursing research within departmental priorities
Takes advantage of opportunities to make presentations in local community regarding research projects, areas of expertise, etc.


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 for assigned clinical trials
Evaluation: Evaluates the effectiveness of nursing care they have planned, administered, or delegated
Evaluates patients response to interventions outlined on study protocol; proposes alternative methods to meet individual patient needs
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