Sr. Research Nurse

General Summary/Purpose

We are currently seeking a Sr. Research Nurse to implement and oversee multiple, single- and multi-site national studies as assigned for the Transplant Oncology and Infectious Disease Clinical Research Center (TOID-CRC) in the Department of Medicine Division of Infectious Diseases. Our primary research focus is the diagnosis, prevention, and treatment of infectious complications in solid organ and bone marrow transplantation. The Sr. Research Nurse should be someone who works well in a fast-paced collaborative atmosphere but can also maintain a high degree of independence. This position will report directly to the TOID-CRC Research Manager and Principal Investigators and work closely with the TOID-CRC Senior Research Program Supervisor.

Specific Duties & Responsibilities

Pre-study:

• Anticipates research requirements for designated patient populations
• Collaborates 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. for assigned protocols
• Collaborates in the determination of roles & responsibilities of research team members in the implementation of assigned trials
• Evaluates the impact on & availability of resources for assigned clinical trials
• Lists & clarifies concerns & questions about new protocols with Research Nurse Manager and PI. Proposes & negotiates alternatives to improve protocol implementation.

Pre-initiation:

• 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, and preprinted orders
• Develops study specific CRFs
• Participates in the development of study specific databases, assuring clinical data is appropriate for answering study specific endpoints
• Develops study specific laboratory and operational manuals
• Ensures regulatory requirements are met for designated studies
• Assures compliance with local, national, and international regulatory standards; as appropriate, prepares & submits required regulatory documents
• Develops training materials for assigned studies/projects
• Monitors for and notifies PI of IRB approval/request for further information as appropriate
• Determines that all approvals for studies have been received prior to initiation of research activity
• Represents Center at research and protocol initiation meetings
• Assures that all elements of a trial are in place before activating subsites
• Participates in communications with protocol sponsors, NIH, and cooperative groups, coordinating plans to address issues with PI.
  

Recruitment & enrollment:

• Responsible for evaluating and assuring recruitment and study/project goals are met by the research team and participating sites.
• Responsible for the development of recruitment strategies to ensure patient accrual within protocol timeframes.
• Prepares and presents study specific updates to Research Manager and Investigators as requested. Identify and provide recommendations to remediate issues of concern

Data Management/Document maintenance:

• Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials.
• Applies clinical/pharmacological knowledge to assure that safety reporting processes for assigned studies are implemented and maintained
• 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 external site 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 TOID SOPs pertaining to performance of clinical research
• Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc.

Staff Education:

• Participates in orientation process for new Clinical Research Nurses and Clinical Research Coordinators, includingthe mentoring and managing of other clinic personnel to promote quality, safety, and excellence in care
• 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.

Other:

• 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.

On-call late and weekend responsibilities are required once per month.

Position requires significant mobility, ability to walk back and forth between university, lab, and hospital.

Must be able to lift 10 pounds overhead, and pickup and carry objects up to 15 pounds.

Minimum Qualifications

Individual must be a registered nurse, licensed in the State of Maryland. 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. Minimum 2 years research experience.

Additional experience may substitute for bachelor's degree. Related master's degree may be considered in lieu of experience. Current American Heart Association or American Red Cross CPR certification required. Must maintain current licensure and certification during duration of employment. Acceptable completion of the JHH or BMC credentialing process is required within two weeks of start date.

JHU Equivalency Formula:18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Classified Title:Sr. Research Nurse
Working Title: Sr. Research Nurse ​​​​​
Role/Level/Range: ACRP/04/MF
Starting Salary Range:$70,805 - $97,435; Commensurate with experience
Employee group: Full Time
Schedule: Monday-Friday, 8:30am-5:00pm plus, Up to 37.5 hours/week
Exempt Status: Exempt
Location: 04-MD:School of Medicine Campus
Department name: 10002813-SOM DOM Infectious Disease
Personnel area: School of Medicine

The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office atjhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

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