Sr. Research Nurse
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Date posted
- May 7, 2021
View more
- Position Type
- Faculty Positions, Health & Medicine, Nursing, Pediatrics, Administrative, Academic Affairs, Research Administration
- Employment Type
- Full Time
General Job Description: Reporting to the Principal Investigator(s) and to the Program Manager, this position is responsible for the coordination and implementation of assigned clinical trials within the research program.
Specific Duties and Responsibilities:
A. Project Management
1. 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
-
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
-
Collaborates in the
development of recruitment strategies to ensure patient accrual
within protocol timeframes
-
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
-
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.
-
Independently/collaboratively
performs responsibilities of Level I
B. Education
1. 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
-
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
-
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.
C. Clinical Practice
1. 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
-
Collaborates with health
care team to coordinate and facilitate protocol requirements for
assigned clinical trials
-
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
D. 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
Requirements:
- 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 experience may substitute for bachelor's degree. Related master's degree may be considered in lieu of experience.
Key
skills, knowledge and abilities:
- Demonstrated knowledge of computer applications and databases and of personal computer systems is highly desirable.
- Ability to demonstrate knowledge and skills necessary to provide care appropriate to the age of the patients served.
- Demonstrate knowledge of the principles of growth and development over the lifespan and possess the ability to assess data reflective of the patient(s) requirements relative to his or her age-specific needs, and to provide the care needed as described in the unit/area/department policies and procedures.
- Knowledge of investigational therapies which require special expertise and clinical care management.
- Highly effective verbal and written communication skills are required.
Classified Title:Sr. Research
Nurse
Working Title: Sr. Research
Nurse
Role/Level/Range: ACRP/04/MF
Starting Salary Range:$70,805 - $83,865; commensurate
with experience
Employee group: Full Time
Schedule: M-F 8:30am- 5:00pm
Exempt Status: Exempt
Location: 04-MD:School of Medicine Campus
Department name: 10002940-Cancer Immunology/GI Clinical
Research
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.
Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until
filled.
EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf
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 at jhurecruitment@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.
Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.
EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm
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