Sr. Research Nurse (Oncology)
Johns Hopkins University
We are seeking a Sr. Research Nurse who will oversee the administrative and scientific implementation of clinical research protocols for complex and/or multiple clinical studies. As part of a study team, collaborates with faculty, develops protocol, develops SOP, and oversees study-related activities for one or more studies.
Specific Duties & 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, pre-printed orders, & distribution of the protocol on the Web Library and Internet (where applicable)
- Assures receipt of protocol by pharmacy for review & input as appropriate.
- Assures compliance with local & national regulatory standards.
- Collaborates with study team and pharmacy to prepare drug data sheets for new trials.
- 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.
- Works with CBT on beacon protocol order sets prior to start up and attends institutional PORSCHE meetings for approval of electronic order sets.
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.
- Manages patients on clinical studies while adhering to all protocol mandates and standard of care clinical practice.
- Assures all clinical protocol deviations are communicated with team for proper documentation and or submission to regulatory agencies.
- 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.
- Works with CBT on beacon protocol order set changes with amendment that require adjustment to original order set plan.
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.
- Collaborate closely with study coordinator on patient updates and clinical issues to ensure prompt, accurate reporting to sponsor or other entities is handled within protocol/ regulatory guidelines.
Education
Patient/Family Education
- Provides initial and 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/in-service programs for clinical team/outpatient treatment nurses and or phlebotomy staff as appropriate.
- Attends and participates in in-service and external trainings, workshops, conferences, and other relevant programs for professional growth and development as relevant.
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 s/he has 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.
- Clinical Responsibilities
- Perform clinical duties as assigned.
Minimum Qualifications
- Individual must be a registered nurse, licensed in the State of Maryland or state where practicing.
- Bachelor's degree in nursing or related discipline required.
- Master's degree strongly preferred.
- Minimum of two years experience in the specialty or a related area required.
- Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Classified Title: Sr. Research Nurse
Role/Level/Range: ACRP/04/MF
Starting Salary Range: $75,100 - $131,700 Annually ($102,400 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday - Friday 8:30 -5:00pm
FLSA Status: Exempt
Location: School of Medicine Campus
Department name: SOM Onc Cancer Immunology/GI Clinical Re
Personnel area: School of Medicine