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Job Req ID:  115284

Sr. Research Nurse

We are seeking a Sr. Research Nurse who will provide research coordination support for complex early phase clinical trials conducted in the Drug Development Unit (DDU) in the Division of Clinical Pharmacology. This position requires a high level of knowledge combining clinical experience with research coordination and data abstraction. The Sr. Research Nurse will collaborate with the study’s clinical team and faculty to implement multiple research protocols and will oversee study related activities.


Specific Duties & Responsibilities

  • The Sr. Research Nurse will manage the day-to-day operations of the study.
  • Maintains regular direct contact and close collaboration with study faculty, including discussions of possible study adverse events and safety concerns that arise with study participants and prospective study participants.
  • Participates in DDU weekly protocol review meetings, monthly conference calls with protocol sponsors, and annual project-specific meetings with contributions to decisions regarding protocol design and modifications, data collection forms, and methods of data capture.
  • Works with study faculty to schedule medical coverage for screening prospective study participants and conducting study visit evaluations.
  • Oversees and supports study visits for non-licensed DDU staff (e.g. study coordinator, clinical research fellow).
  • Plans and manages all phases of study recruitment for assigned protocols
  • Coordinates laboratory testing for study participants, including coordinating scheduling tissue biopsy procedures with Hospital clinical services, JHBR lab, and Clinical Pharmacology Analytical Laboratory (CPAL) staff.
  • Attends and assists physicians during tissue biopsy and fluid collection procedures.
  • Transports specimens to clinical and research laboratories.
  • Works with study pharmacists regarding possible protocol deviations and weekly anticipated dosing needs.
  • At the direction of the Clinical Pharmacology faculty, assists in ordering research doses of radioisotopes from a commercial radiopharmacy.
  • Prepares for and participates in study monitor visits.
  • Tracks and coordinates regulatory materials needed for study continuation, including Institutional Review Board, Institute for Clinical and Translational Research, and Food and Drug Administration Investigational New Drug Applications, as well as document requirements from study sponsors.
  • Assists study investigators with drafting and revising protocol documents for NIH review.
  • Applies knowledge of and compliance with institutional and external clinical research guidelines, as well as DDU specific Standard Operating Procedures.
  • Assist in monitoring the data integrity of studies assigned to other research nurse coordinators using Quality Assurance forms maintained by the DDU.
  • Oversees the clinical assessments of study subjects, including but not limited to screening, evaluation and testing.
  • Develops workflow policies and procedures, including drafting clinical instruction sheets to follow study protocol evaluations.
  • Prepares study manuals and documents, including patient charts, specimen collection materials, clinical test logs, and specimen drop-off and documentation logs.
  • Provide direct clinical care to research participants within the scope of a nursing license.
  • Administer study medications.
  • Specimen collection, including phlebotomy, and placement of peripheral intravenous catheters.
  • Performs Point of Care (POC) testing.
  • Oversees data collection, processing, storage, inventory, and quality control.
  • Obtains informed consent under the general supervision of the investigators and educates participants regarding study requirements.
  • Participates in preparing complex data gathered during the clinical research study for analysis and interpretation.
  • Works with principal investigator to define information and plans required to accomplish individual protocol timelines and goals.
  • Regularly reviews data to ensure completeness, accuracy, and timeliness of data collection.
  • As needed provide training for new staff members in areas of coordinating clinical workflow with clinical trial management.
  • Schedules research follow-up appointments.
  • Monitors patient accrual and follow-up appointments.
  • Additional responsibilities include research medication administration; assessment for local and/or systemic reactions to study interventions; intravenous access placement and maintenance; blood sampling from intravenous access; medical history gathering; provision of counseling to reduce or avoid risk of blood-borne infections; phlebotomy; urine specimen collection; assistance with specimen preparation, storage, and transport; data collection and documentation; assistance with report generation and sponsor notification regarding adverse events and new-onset illnesses; maintaining nursing credentials and required university trainings.


Minimum Qualifications
  • The individual must be a registered nurse, licensed in the State of Maryland or the state where practicing. Bachelor's degree in nursing or related discipline required. A master's degree is strongly preferred.
  • Minimum of two years' experience in the specialty or a related are required.
  • Additional experience may substitute for a bachelor's degree and related master's degree may be considered in lieu of experience.


Preferred Qualifications
  • Preferred experience in phlebotomy and peripheral intravenous catheter placement.

 

 

Classified Title: Sr. Research Nurse    
Role/Level/Range: ACRP/04/MF  
Starting Salary Range: $75,100 - $131,700 Annually ($100,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: Monday-Friday, 8:30am-5:00pm 
Exempt Status: Exempt 
Location: School of Medicine Campus 
Department name: ​​​​​​​SOM DOM Clinical Pharmacology  
Personnel area: School of Medicine 

 

 

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.

Education and Experience Equivalency
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: 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 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 Completing Studies
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.

Background Checks
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. 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. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. 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 upon 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.
School of Medicine - East Baltimore Campus

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