The department of Oncology is seeking a Sr. Research Nurse to work under Sibley Memorial Hospital Medical and Radiation Oncology. Will be responsible for the coordination and implementation of assigned clinical trials within the research program. Collaborates with health care team to coordinate and facilitate protocol requirements for assigned clinical and research trials.

Specific Duties & Responsibilities

Project Management

Pre-study

• Anticipates research requirements for designated patient populations.
• May collaborate in development & writing of protocols and consent forms.
• Collaborates in development and preparation of regulatory documents.
• 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.
• Provides copy of study and pre-printed data forms to Data Management office for review and approval.
• Prepares GCRC and PCRU protocol submissions.
• Assures receipt of protocol by pharmacy for review & input.
• Communicates with coordinating center and provides necessary documentation (i.e., Cvs, 1572, lab licenses, normal values, IRB submissions, etc.)
• 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.
• Monitors for and notifies PI of IRB approval/request for further information.
• 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.
• Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes.

Data collection/document maintenance

• 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.
• 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.

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/in-service programs for Clinical Research Nurses, Clinical Associates, Data Managers, 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.

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

• Identify 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/patient populations.

Evaluation

• Evaluates the effectiveness of nursing care that has been 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.

Supervisory Responsibilities

• Provides supervision and oversight of Clinical Associates as assigned.

• Bachelor's Degree in Nursing or related discipline.
• Individual must be a registered nurse, licensed in the State of MD or state where practicing.
• Two year's experience in the specialty or a related area.
• Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.

• Master's Degree.

Classified Title: Sr. Research Nurse 
Role/Level/Range: ACRP/04/MF  
Starting Salary Range: $75,100 - $131,700 Annually ($103,400 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F/8:30-5:00pm 
Exempt Status: Exempt 
Location: District of Columbia 
Department name: ???????SOM Onc Sibley  
Personnel area: School of Medicine 

About Johns Hopkins University

Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.

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