Research Nurse

Location
Maryland, United States
Salary
Salary Not Specified
Posted
Nov 05, 2020
Employment Type
Full Time

General Summary/Purpose:

The Research Nurse will be responsible for the oversight of the administrative and scientific implementation of one or more Pediatric Gastroenterology and Hepatology studies. Provides clinical nursing care directly to patients/families involved in clinical research, through the integration of specialty knowledge and expert clinical reasoning and through the application of the nursing process in a research setting. Job requires utilizing a thorough knowledge of concepts and theories in research studies and associated protocols for the design, implementation, oversight and analysis of clinical trials. Job requires collaboration with faculty, research staff, clinical research unit staff, lab staff, IRB, external study sponsors and various internal staff members on development, implementation, and management of various research studies. Candidate will have a direct reporting relationship with the Principle Investigator(s).

Specific Duties & Responsibilities:

45% Study Nurse:

  • Pre-study: Anticipate research requirements for designated patient populations. Review and assess new protocols for clarity, feasibility, maintenance of subject safety. Review prospective reimbursement analysis (PRA) as appropriate.
  • Pre-initiation: As appropriate, prepare & submit protocol & consent forms to the IRB; prepare other forms required for study initiation (pre-printed orders, eligibility checklists, etc.). Determine that IRB approval has been received prior to initiation of research activity. Participate in study initiation meetings and prepare space for study-related equipment & supplies.Assist PI(s) implementation and coordination of assigned study/studies.
  • Recruitment & enrollment: Ensure subject eligibility for assigned research studies. Screen potential research subjects for participation in clinical trials (incl. Review of medical history, concomitant meds, pathology, and other relevant documents). As appropriate, obtain informed consent from research subjects. In conjunction with PI, monitor protocol enrollment goals.
  • Regulatory and document maintenance:Assist staff with necessary IRB training and other regulatory requirements. Develop, implement, and maintain SOPs. Based on study protocols create study documentation and case report forms. Based on research protocols design regulatory binders for studies and oversee maintenance for the life cycle of the study. Ensure that studies comply with applicable regulations and guidelines, including GCP, and that staff adhere to study protocols and procedures. Ensure that study is conducted according to all applicable regulations and guidelines and adhere to standard operating procedures specified in protocol manual.
  • Quality Assurance:Develop, implement and ensure compliance of QA/QC activities related to all studies. Recognize and document adverse events per protocol and ensure reporting to appropriate study & regulatory personnel. Initiate adverse event reports and ensure proper and timely distribution to sponsor and IRB. Prepare for and respond to study audits in a timely fashion.
  • Communication: Assist in completion of annual periodic review of data for reporting to IRB and sponsor. Communicate effectively with subject & family of active and prospective study participants. Communicate effectively and meet regularly with members of the research team to review protocol progress and data collection. Complete required documentation for accreditation and annual reviews in a timely fashion.Act as contact between PI(s) and other research sites and institutional partners. Participate in monthly/bi-weekly coordinator and committee calls as required by individual studies.

40% Nursing activities related to research:

  • Schedule, perform, and/or monitor procedures and tests per protocol requirements and to ensure results available in timely manner
  • Perform patient assessment, vital signs, collection of blood, urine, and/or stool specimens
  • Administer appropriate developmental assessments and questionnaires
  • Provide nursing care as needed for subjects/families in a research setting
  • Obtain and ensure proper distribution of required bio-specimens, including specimens obtained in clinical or operating room settings
  • Develop and/or ensure availability of appropriate protocol and treatment-specific patient education materials
  • Determine effectiveness of patient/family education and modify the education plan to most effectively address patient/family needs
  • Demonstrate and teach appropriate medication administration including subcutaneous injection and oral medication administration, storage to subjects/families
  • Monitor patient compliance with medication diaries
  • Assess and ensure subject safety throughout participation in trial
  • Monitor patients with medical problems related to study
  • Recognize common laboratory values and alerts appropriate individuals for clinically significant deviations
  • Present PI(s) with relevant information for determination of seriousness, causality, and intervention for adverse event
  • Act on the PI’s recommendation for adverse event intervention
  • Maintain follow-up to determine resolution of adverse event
  • As appropriate, perform phlebotomy per policy and procedures

15% Data Management:

  • Obtain required data through chart review, telephone communication, subject interview and assessment
  • Monitor data compliance with requirements of assigned research
  • Complete data entry into study data systems in a timely manner
  • Respond to and complete data requests and query resolution by study sponsors in a timely manner

Perform other duties as assigned.

Minimum Qualifications (mandatory):

  • Must be a registered nurse, licensed in the State of Maryland or state where practicing.
  • Current CPR certification.

Preferred Qualifications:

  • Bachelor's degree in nursing or related discipline preferred.
  • Master's degree strongly preferred.
  • Three (3) years as a registered nurse with a minimum of two (2) years of research experience; strongly preferred but not required.

Special Knowledge, Skills, and Abilities:

  • Ability to work independently, exercise discretion and mature judgment, and manage multiple priorities simultaneously.
  • Strong written, verbal, and interpersonal communication skills.
  • Detail oriented, well organized, self-motivated, time management skills, general computer knowledge.

Classified Title:Research Nurse
Working Title: Research Nurse ​​​​​
Role/Level/Range: ACRP/03/ME
Starting Salary Range:$60,945-$83,865 (commensurate with experience)
Employee group: Full Time
Schedule: Monday-Friday/8:30am-5:00pm
Exempt Status: Exempt
Location: 04-MD:School of Medicine Campus
Department name: 10003078-SOM Ped Gastroenterology
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

School of Medicine - East Baltimore Campus


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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