Clinical Research Nurse

The Johns Hopkins Emergency Medicine, Division of Research and Innovation is seeking an energetic and devoted Clinical Research Nurse to support our exciting programs. The successful candidate will be responsible for pre-initiation and implementation of clinical research activities, staff and patient education, recruitment and enrollment, data collection, quality assurance, and program evaluation. The incumbent will also help develop, prepare, and submit publications and grant/contract proposals for complex and/or multiple research studies

Specific Duties & Responsibilities:

Pre-study Initiation

• Anticipates research requirements for designated patient populations
• With guidance, reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintenance of subject safety
• With guidance, lists & clarifies concerns and questions about new protocols with PIs, Managers and sponsors
• With guidance, evaluates the impact on and availability of resources for assigned clinical trials
• As appropriate & with guidance, prepares & submits documents to the IRB
• With guidance, prepares other forms required for study initiation (pre-printed orders, eligibility checklists, etc.)
• Determines that IRB approval has been received prior to initiation of research activity
• Participates in study initiation meetings
• Prepares space for study-related equipment & supplies

Recruitment & Enrollment

• Ensures initial & ongoing eligibility of all subjects for assigned research studies
• Screens potential research subjects for participation in clinical trials (including review of medical history, concomitant meds, pathology, other relevant documents)
• Evaluates ongoing eligibility of research subjects’ participation in clinical trials; collaborates with Principal Investigators to obtain exemptions as appropriate
• Abstracts data from a variety of sources to complete pre-study work-up
• Demonstrates understanding of the informed consent process
• With guidance and as appropriate, obtains informed consent from research subjects
• As appropriate, documents obtaining of informed consent in medical record
• Registers research subjects per sponsor guidelines
• Demonstrates knowledge of protocol endpoint definitions
• In collaboration with research and healthcare teams, evaluates potential subjects for research participation

Data Collection/Document Maintenance

• Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials
• Obtains & ensures proper distribution of required pharmacokinetic & tissue samples
• Schedules, performs, and/or monitors procedures & tests per protocol requirements
• Ensures correct documentation of clinical study in medical record and appropriate protocol documents. Schedules visits, tests & procedures for patients entered in clinical trials to ensure results are available in a timely manner
• As appropriate, ensures all required signatures are obtained on informed consent documents
• As appropriate, ensures validity of available informed consent documents
• Develops procedure and collection forms for pharmacokinetic sampling
• With guidance & as dictated by research protocol, obtains required data through chart review, telephone communication, subject interview & assessment
• Coordinates with data managers to ensure delivery of trial data for inclusion into study files
• As appropriate, & with assistance as needed, orders required medical equipment & supplies
• Maintains working knowledge of institutional information systems for correctly scheduling clinical tests & procedures and extracting data
• With guidance, organizes own time & sets priorities for research-related functions
• With guidance, able to prioritize workload & manage multiple projects effectively
• Achieves and maintains a working knowledge of computer software specific to department, including word processing, e-mail & internet functions
• Aware of & knowledgeable about departmental Standard Operating Procedures

Quality Assurance

• Evaluates outcomes of assigned clinical trials
• Recognizes and documents adverse events per protocol & ensures reporting to appropriate study & regulatory personnel; with guidance, initiates adverse event reports and ensures proper and timely distribution to sponsor and IRB
• Grades identified toxicities per NCI or protocol-specific criteria
• Attends medical staff meetings to review study progress
• In collaboration with other members of the research team, prepares for and responds to study audits.

Communication

• With guidance, assists in completion of annual periodic review of data for reporting to IRB, protocol sponsors, & cooperative groups
• Documents written & verbal communication with study contacts
• Communicates effectively with subject & family of active and prospective study participants
• Communicates effectively with members of the health care and research teams
• Meets regularly with other members of the research team to review protocol progress and data collection
• Attends and participates in meetings of the research nurse group; completes required documentation for accreditation and annual reviews in a timely fashion
• Attains proficiency in Web-based communication
• Demonstrates understanding of the rules for advertising for subject participation, where appropriate

Education

• Ensures that patient and staff education needs are met with regard to assigned protocols
• Ensures development and/or availability of appropriate protocol- and/or treatment-specific patient education materials
• Determines effectiveness of patient/family education & modifies the education plan to most effectively address patient/family needs
• Identifies staff learning needs, including those based on requirements specific to designated research protocols
• Trains research staff on phlebotomy and use of medical equipment
• Ensures development & availability of appropriate staff education materials
• Provides staff education related to assigned clinical trials (i.e., in-services)
• Attends and participates in in-service and external trainings, workshops, conferences, and other relevant and/or required programs for professional growth and development

Clinical Practice

• Organizes own time & sets priorities for a group of patients on a research protocol
• Plans for research related activities while understanding patient’s current medical problems
• Utilizes available resources to meet patient care needs
• Utilizes health care team members in planning care
• Coordinates care that involves other health care disciplines or resources to provide continuity and assist in patient compliance with protocol requirements

Implementation

• Assesses and ensures subject safety throughout participation in trial; assists patients with medical problems related to study
• Recognizes common laboratory values and alerts appropriate individuals for clinically significant deviations
• Presents PI with relevant information for determination of seriousness, causality, & intervention for adverse events
• Acts on the PI’s recommendation for adverse event intervention
• Maintains follow-up to determine resolution of adverse event
• As appropriate, performs phlebotomy per policy & procedures
• Complies with institutional infection control policies
• Documents the implementation of nursing care & patient’s response in accordance with the established standards of internal & external agencies
• Performs complex treatments correctly & safely
• Documents telephone and other communications with patients per institutional policy

Consultation

• Communicates data from clinical trials relevant to patient management to community-based health care personnel

Minimum Qualifications (Mandatory):

• Current licensure in the State of Maryland or state where practicing as a Registered Nurse is required.

Preferred Qualifications:

• Baccalaureate Degree in Nursing, or Registered Nurse with 2 years full-time clinical experience
• 2 years full-time clinical direct patient care experience; 3 years if non-BSN
• Bilingual English and Spanish speaker

Special Knowledge, Skills & Abilities:

• Ability to demonstrate knowledge and skills necessary to provide care appropriate to the age of patients served
• The individual must demonstrate knowledge of the principles of growth and development over the life span 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
• Highly effective verbal and written communication skills are required

Physical Requirements:

• This position requires the candidate to meet a flexible schedule, with the ability to work some nights and weekends per study requirements, along with the ability to meet short deadlines and to travel domestically and internationally
• Work schedules are determined by protocol activity and may demand flexible and/or extended work hours
• Possible exposure to communicable diseases, hazardous materials, and pharmacologic agents
• Safety regulations must be followed

Supervisory Responsibility:

• May supervise 4-6 Research Coordinators and students

Classified Title: Research Nurse
Working Title: Clinical Research Nurse
Role/Level/Range: ACRP/03/ME
Starting Salary Range: ​​​​​​​$61,550 - $84,700 annually (commensurate with experience)
Employee group: Full Time
Schedule: Varies; 7.5 hour shifts
Exempt Status: Exempt
Location: ​​​​​​​School of Medicine Campus
Department name: ​​​​​​​SOM Em Med 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 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.

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