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Job Req ID:  80036

Sr. Research Nurse

The Department of Cardiology is seeking a Senior Research Nurse. The Sr. Research Nurse is responsible for the coordination and implementation of assigned clinical trials within the research program. Oversees the administrative and scientific implementation of clinical research protocol for complex and/or multiple research studies. As part of study team, collaborates with faculty, develops protocol, develops SOP, and oversees study-related activities for one or more studies.

 

Specific Duties & Responsibilities:

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 IRB, GCRC, PCRU and ICTR protocol submissions as appropriate.
  • Assures receipt of protocol by pharmacy for review & input as appropriate. 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.

 

Recruitment & Enrollment:

  • Ensures initial & ongoing eligibility of all subjects for assigned research studies.
  • Screens potential research subjects for participation in clinical trials (incl. Review of medical history, concomitant meds, pathology, and other relevant documents).
  • Evaluates ongoing eligibility of research subjects’ participation in clinical trials; collaborates with Principal Investigator to obtain exemptions as appropriate.
  • Abstracts data from a variety of sources to complete pre-study work-up.
  • Demonstrates and participates in the informed consent process.
  • As appropriate, documents obtaining of informed consent in medical record. Registers research subjects per sponsor guidelines.
  • In conjunction with PI, monitors protocol enrollment goals.
  • Demonstrates knowledge of protocol endpoint definitions.
  • In collaboration with healthcare team, evaluates potential subjects for research participation. Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes.
  • Scheduled evening and weekend on-call may be required.

 

Data Collection/Document Maintenance:

  • Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials.
  • Data entry utilizing both web-based, Microsoft EXCEL and ACCESS with the ability to setup and query databases as needed, including but not limited to (REDCap).
  • Performs nursing procedures associated with cardiac stress testing, including testing performed with MRI. Assists in screening patients for MRI eligibility and assisting during MRI exam.
  • 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.
  • Maintains a protocol database or spreadsheet for tracking patient activity and data submission. Prepares reports on individual patients or the study as required by the PI, DSMB or regulatory agency.
  • Prepares for and participates in monitoring and audits of studies.

 

Quality Assurance:

  • 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.

 

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.

 

Other duties and responsibilities as assigned or required.

 

Minimum Qualifications (Mandatory):

  • 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 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.
  • Current American Heart Association CPR certification required, ACLS preferred. Must maintain current licensure and certification during duration of employment. Acceptable completion of the JHU credentialing process is required prior to start date.

 

JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience.  Additional related experience may substitute for the 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. 

 

** Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date. 

 

Physical Requirements:

  • Sitting in a normal seated position for extended periods of time.
  • Reaching by extending hand(s) or arm(s) in any direction.
  • Finger dexterity to manipulate objects with fingers rather than with whole hand or arm, for example, using a keyboard.
  • Able to escort subjects participating in studies throughout the hospital, including into and out of MRI exams.
  • Communication skills using the spoken word.
  • Ability to see within normal parameters, to hear within normal ranges and move about.

 

Classified Title: Sr. Research Nurse
Role/Level/Range: ACRP/04/MF 
Starting Salary Range: $71,510 - $98,410 annually (commensurate with experience)
Employee group: Full Time 
Schedule: M-F 8:30am - 5:oopm 
Exempt Status: Exempt 
Location: ​​​​​​​School of Medicine Campus 

Department name: ​​​​​​​SOM DOM Cardiology 
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 at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

 

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

 

The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.

 

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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