We are seeking a Sr. Research Nurse who will be responsible for the coordination and implementation of assigned clinical trials within the research program.

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, 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.

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 precepting.
• 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.
• 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 patient's 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.

• Individual must be a Registered Nurse.
• Bachelor's Degree in Nursing or related discipline.
• Minimum of two years of experience in the specialty or a related area.
• Additional experience may substitute for Bachelor's Degree and related Master's Degree may be considered in lieu of experience

• 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 w/exp.) 
Employee group: Full Time 
Schedule: Mon-Fri / 8a-5:30p 
FLSA Status: Exempt 
Location: School of Medicine Campus  
Department name: SOM Onc Hematologic Malignancies   
Personnel area: School of Medicine 

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About Johns Hopkins University

The Johns Hopkins University (JHU) was founded in 1876 as the nation's first research university, dedicated to bringing the benefits of discovery to the world. JHU is the largest private employer in Baltimore and Maryland, making a large economic impact in the city and state. We enroll more than 30,000 full- and part-time students across ten academic divisions, offering in-person and remote learning in over 400 programs. Not only are we located in Baltimore, but we also have a presence in Washington, D.C.

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